{ "schemaVersion": 1, "templateVersion": "committee-packet-v1", "capturedAt": "2026-11-09T02:26:30.977Z", "illustrative": true, "dataset": { "verifiedAt": "2026-08-31", "directorySha256": "0e79701d02a2fbba6db8ae2901c7d98278db4f78200060fab738ec8bf4c97180", "indexSha256": "eee0ba31e8c00f20ebf412c13ec136630a45a73b1bad4962bb198cb4356950ca", "selected": [ { "slug": "mammoscreen-5-k260714", "submissionNumber": "K260714", "entrySha256": "ad0e090679d063f5f76bcb064cbf553b81ab7f238bc53e02bccd5b102a64b271", "detailSha256": "b0882284f547423019c6c5e1998d52f277c1e93c427d9c804973747d621238b9" }, { "slug": "transpara-2-1-0-k241831", "submissionNumber": "K241831", "entrySha256": "e95f845519c689b9b849eb90b688a2d4bf4263ca6538eae8ba883fda945a016a", "detailSha256": "cb91d57d89bba841582e44c4a9dd70762eed2bbbbee74b2fc2fcfba48ccfdd20" } ] }, "entries": [ { "slug": "mammoscreen-5-k260714", "name": "MammoScreen® (5)", "vendor": "Therapixel", "vendorSlug": "therapixel", "submissionNumber": "K260714", "fdaStatus": "FDA-cleared", "fdaClearanceType": "510(k)", "decisionDate": "2026-06-26", "modality": "Mammography/DBT", "modalitySlug": "mammography-dbt", "anatomy": "Breast", "anatomySlug": "breast", "bodyRegionIds": [ "breast" ], "compatibility": [ { "id": "mammoscreen-ge", "submissionNumber": "K260714", "systemId": "ge-mammography-input", "systemName": "GE FFDM/DBT input", "systemVersion": null, "productVersion": "MammoScreen 5", "state": "conditional_support", "scope": "exact_submission", "basis": "current", "geography": "United States labeling", "configuration": "FDA-labeled FFDM/DBT input from compatible GE equipment; a software build is not identified.", "conditions": [ "Confirm the precise acquisition model, software, priors and supported scenarios against the release-specific labeling." ], "localTest": "Route representative labeled exams and verify study identity, findings, reporting and fallback review.", "reviewedAt": "2026-11-06", "note": "Source documentation describes this scope; local installed-system acceptance remains open.", "sources": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" } ], "localAcceptance": "not_performed" }, { "id": "mammoscreen-hologic", "submissionNumber": "K260714", "systemId": "hologic-mammography-input", "systemName": "Hologic FFDM/DBT input", "systemVersion": null, "productVersion": "MammoScreen 5", "state": "conditional_support", "scope": "exact_submission", "basis": "current", "geography": "United States labeling", "configuration": "FDA-labeled FFDM/DBT input from compatible Hologic equipment; a software build is not identified.", "conditions": [ "Confirm the precise acquisition model, software and current/prior image scenarios; do not extend the claim to every Hologic configuration." ], "localTest": "Test the agreed inputs and exclusions, findings, initial report and retained physician review.", "reviewedAt": "2026-11-06", "note": "Source documentation describes this scope; local installed-system acceptance remains open.", "sources": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" } ], "localAcceptance": "not_performed" }, { "id": "mammoscreen-merge-context", "submissionNumber": "K260714", "systemId": "merge-pacs", "systemName": "Merge PACS", "systemVersion": null, "productVersion": null, "state": "not_reviewed", "scope": "product_family", "basis": "broader_scope", "geography": "Geography not established for this exact pairing", "configuration": "Merge describes mammography integrations including Therapixel. The source does not identify MammoScreen 5 and a specific Merge build.", "conditions": [ "A supplier-family integration statement is context, not qualification of this FDA record or site installation." ], "localTest": "Obtain the two exact builds, licensed interface and conformance/acceptance evidence from both suppliers.", "reviewedAt": "2026-11-06", "note": "Broader product-family or vendor context. The exact AI release and system build pairing is not reviewed.", "sources": [ { "id": "phase3-merge-integration-context", "title": "Merge PACS: AI integration and mammography context", "url": "https://www.merge.com/blog/8-requirements-merge-pacs-reliable-imaging", "publisher": "Merge" } ], "localAcceptance": "not_performed" } ], "workflowRoles": [ "interpretation" ], "workflowReviewState": "source_reviewed", "clinicalUse": "Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.", "useCases": [ "Breast imaging" ], "useCaseSlugs": [ "breast-imaging" ], "fdaSourceUrl": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "facts": { "purpose": { "value": "Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "wave21-worker4-fda-k260714" ], "lastVerified": "2026-09-05" }, "anatomy": { "value": "Breast", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "wave21-worker4-fda-k260714" ], "lastVerified": "2026-09-05" }, "intendedUsers": { "value": "Physicians interpreting screening mammograms.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "wave21-worker4-fda-k260714" ], "lastVerified": "2026-09-05" }, "careSetting": { "value": "Screening mammography workflow.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "wave21-worker4-fda-k260714" ], "lastVerified": "2026-09-05" }, "workflowRole": { "value": "Concurrent reading/reporting aid; includes an initial report populated with selected findings.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "wave21-worker4-fda-k260714" ], "lastVerified": "2026-09-05" }, "input": { "value": "Compatible GE or Hologic FFDM or DBT screening exams, with optional priors; supplementary XCCM, XCCL and ML views are supported in specified scenarios.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "wave21-worker4-fda-k260714" ], "lastVerified": "2026-09-05" }, "output": { "value": "Finding-, breast- and case-level scores from 1 to 10, locations and finding marks for masses, asymmetries, distortions and calcifications.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "wave21-worker4-fda-k260714" ], "lastVerified": "2026-09-05" }, "integration": { "value": "Current MammoScreen family documentation describes a site virtual gateway, DICOM Secondary Capture and Structured Report output, and optional EMR/reporting API integration using HL7/FHIR.", "status": "vendor_supplied", "applicability": "product_family", "sourceIds": [ "wave21-worker4-mammoscreen-integration" ], "lastVerified": "2026-09-06", "note": "Current family documentation, not evidence that every interface or package shipped with the cleared version." }, "deployment": { "value": "Current family documentation describes a site gateway with cloud computation and an on-premises option available on request.", "status": "vendor_supplied", "applicability": "product_family", "sourceIds": [ "wave21-worker4-mammoscreen-integration" ], "lastVerified": "2026-09-06" }, "security": { "value": "Therapixel's own page says Therapixel and its operations for MammoScreen are ISO/IEC 27001 certified by an independent certification body. The page gives no certificate number, scope statement, issue date or expiry, and the certificate was not read.", "status": "vendor_supplied", "applicability": "vendor_wide", "sourceIds": [ "w27-therapixel-iso27001" ], "lastVerified": "2026-10-25", "note": "Vendor-wide statement, not an independent attestation. It does not establish certificate or report scope for this exact release, expiry, data location, retention, identity and access, or incident-response terms for a deployed configuration. Obtain these from the vendor." }, "pricing": { "value": null, "status": "unknown", "applicability": "exact_product_version", "unknownReason": "not_public", "sourceIds": [], "lastVerified": "2026-09-06", "note": "No public price or contract for MammoScreen 5 was located in the reviewed vendor material." }, "reimbursement": { "value": null, "status": "unknown", "applicability": "exact_submission", "unknownReason": "not_public", "sourceIds": [], "lastVerified": "2026-10-26", "note": "Bounded web search on 2026-10-26 (query: \"Therapixel MammoScreen reimbursement CPT coverage\"; top results reviewed) found no vendor or payer page stating coding, coverage or payment for this product. Therapixel's adoption page describes general US screening mammography policy; it states no coding or payment for this product. This records what was found, not that none exists; eligibility depends on payer, site of service and use case." }, "evidenceSummary": { "value": "Regulatory performance evidence is from the prior MammoScreen 3 clinical dataset, not a new MammoScreen 5 clinical study.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "wave21-worker4-fda-k260714" ], "lastVerified": "2026-09-05" }, "monitoring": { "value": null, "status": "unknown", "applicability": "exact_product_version", "unknownReason": "vendor_confirmation_pending", "sourceIds": [], "lastVerified": "2026-09-06", "note": "No site monitoring or update-acceptance procedure was established." }, "limitations": { "value": "Not a standalone diagnostic device and not a substitute for physician review; the MammoScreen 5 algorithm is unchanged from MammoScreen 4.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "wave21-worker4-fda-k260714" ], "lastVerified": "2026-09-05" }, "training": { "value": "The vendor offers a limited-time pilot with remote installation and training.", "status": "vendor_supplied", "applicability": "product_family", "sourceIds": [ "wave21-worker4-mammoscreen-pilot" ], "lastVerified": "2026-09-06", "note": "Duration, curriculum and applicability to version 5 are not stated." } }, "prices": { "primary": [], "context": [] }, "sourceRecords": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" }, { "id": "wave21-worker4-mammoscreen-integration", "title": "MammoScreen integration", "url": "https://www.mammoscreen.com/integration", "publisher": "Therapixel / MammoScreen" }, { "id": "wave21-worker4-mammoscreen-pilot", "title": "Try MammoScreen", "url": "https://www.mammoscreen.com/try-mammoscreen", "publisher": "Therapixel / MammoScreen" }, { "id": "w27-therapixel-iso27001", "title": "Therapixel is now ISO/IEC 27001 certified", "url": "https://www.therapixel.com/therapixel-is-iso27001-certified/", "publisher": "Therapixel" }, { "id": "phase3-merge-integration-context", "title": "Merge PACS: AI integration and mammography context", "url": "https://www.merge.com/blog/8-requirements-merge-pacs-reliable-imaging", "publisher": "Merge" } ], "evidenceMetricCount": 0, "readinessPercent": 78, "researchPercent": 100, "researchStatus": "human_reviewed", "oneLineSummary": "Authorized purpose: Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.", "readerContentStatus": "source_reviewed", "pricingStateLabel": "Not publicly available", "searchTokens": [ "mammoscreen", "5", "therapixel", "k260714", "mammography", "dbt", "breast", "flags", "calcifications", "masses", "asymmetries", "and", "architectural", "distortions", "on", "compatible", "ffdm", "or", "screening", "examinations", "management", "must", "not", "be", "based", "solely", "output", "imaging", "authorized", "purpose", "reading", "aid" ] }, { "slug": "transpara-2-1-0-k241831", "name": "Transpara (2.1.0)", "vendor": "ScreenPoint Medical B.V.", "vendorSlug": "screenpoint-medical-b-v", "submissionNumber": "K241831", "fdaStatus": "FDA-cleared", "fdaClearanceType": "510(k)", "decisionDate": "2024-11-25", "modality": "Mammography/DBT", "modalitySlug": "mammography-dbt", "anatomy": "Breast; regions suspicious for cancer on screening mammography and digital breast tomosynthesis", "anatomySlug": "breast-regions-suspicious-for-cancer-on-screening-mammography-and-digital-breast-tomosynthesis", "bodyRegionIds": [ "breast" ], "compatibility": [ { "id": "transpara-sectra-context", "submissionNumber": "K241831", "systemId": "sectra-ids7", "systemName": "Sectra IDS7", "systemVersion": null, "productVersion": null, "state": "not_reviewed", "scope": "product_family", "basis": "broader_scope", "geography": "Geography not established for this exact pairing", "configuration": "Sectra lists Transpara results in IDS7, MG CAD SR/SC, overlays and worklist integration. The compatible PACS version must be confirmed.", "conditions": [ "The marketplace listing does not bind Transpara 2.1.0 in K241831 to a named IDS7 build." ], "localTest": "Confirm the AI release, IDS7/Core build, licensed integration and region, then test marks, scores, workflow and failure handling.", "reviewedAt": "2026-11-06", "note": "Broader product-family or vendor context. The exact AI release and system build pairing is not reviewed.", "sources": [ { "id": "phase3-sectra-transpara", "title": "Sectra Amplifier Marketplace: Transpara Breast AI", "url": "https://amplifiermarketplace.sectra.com/application/transpara/", "publisher": "Sectra" } ], "localAcceptance": "not_performed" } ], "workflowRoles": [], "workflowReviewState": "not_reviewed", "clinicalUse": "Transpara 2.1.0 is a concurrent reading aid for physicians interpreting screening full-field digital mammography and digital breast tomosynthesis, providing region and examination scores to support review of suspicious breast findings.", "useCases": [ "Breast imaging" ], "useCaseSlugs": [ "breast-imaging" ], "fdaSourceUrl": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "facts": { "purpose": { "value": "Transpara 2.1.0 is a concurrent reading aid for physicians interpreting screening full-field digital mammography and digital breast tomosynthesis, providing region and examination scores to support review of suspicious breast findings.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "fda-k241831" ], "lastVerified": "2026-09-04" }, "anatomy": { "value": "Breast; regions suspicious for cancer on screening mammography and digital breast tomosynthesis", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "fda-k241831" ], "lastVerified": "2026-09-04" }, "intendedUsers": { "value": "Physicians qualified to interpret screening mammography and digital breast tomosynthesis.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "fda-k241831" ], "lastVerified": "2026-09-04" }, "careSetting": { "value": "Healthcare facilities performing screening mammography and digital breast tomosynthesis.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "fda-k241831" ], "lastVerified": "2026-09-04" }, "workflowRole": { "value": "Concurrent reading aid for screening mammography and DBT interpretation.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "fda-k241831" ], "lastVerified": "2026-09-04" }, "input": { "value": "DICOM full-field digital mammography and digital breast tomosynthesis examinations from compatible systems.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "fda-k241831" ], "lastVerified": "2026-09-04" }, "output": { "value": "DICOM mammography CAD results with marked calcification groups, soft-tissue regions, region scores, and an examination score.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "fda-k241831" ], "lastVerified": "2026-09-04" }, "integration": { "value": "The FDA package describes DICOM mammography input and CAD output to a workstation, PACS, or RIS through a standalone processing appliance and third-party workstation interface.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "fda-k241831" ], "lastVerified": "2026-09-04" }, "deployment": { "value": "The FDA package describes a standalone processing appliance with a third-party workstation interface; current hosting, contracts, availability, security, and site configuration remain unknown.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "fda-k241831" ], "lastVerified": "2026-09-04" }, "security": { "value": "ScreenPoint Medical's security reporting page states its security program is aligned with ISO/IEC 27001 and describes a vulnerability reporting channel for Transpara. It states alignment, not certification; no controls are listed. Vendor-wide.", "status": "vendor_supplied", "applicability": "vendor_wide", "sourceIds": [ "w29-screenpoint-security" ], "lastVerified": "2026-10-25", "note": "Vendor statement, not an attestation; exact-release scope is not established." }, "pricing": { "value": null, "status": "unknown", "applicability": "exact_submission", "unknownReason": "not_public", "sourceIds": [], "lastVerified": "2026-09-04", "note": "No public list price or commercial contract for the exact submission and version was identified." }, "reimbursement": { "value": null, "status": "unknown", "applicability": "exact_submission", "unknownReason": "not_public", "sourceIds": [], "lastVerified": "2026-09-04", "note": "No exact-product payer coverage or reimbursement determination was identified in reviewed public material." }, "evidenceSummary": { "value": "K241831 FDA decision material reports the exact evidence metrics included below for Transpara 2.1.0; values are limited to the stated endpoint, population, and operating point.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "fda-k241831" ], "lastVerified": "2026-09-04" }, "monitoring": { "value": "Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K241831.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "fda-k241831" ], "lastVerified": "2026-09-04" }, "limitations": { "value": "The FDA labeling states that the output is not the sole basis for patient management. Use is limited to compatible screening FFDM and DBT and requires physician review; the software does not replace interpretation.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "fda-k241831" ], "lastVerified": "2026-09-04" }, "training": { "value": "Use by physicians qualified to interpret screening mammography and digital breast tomosynthesis. Follow the exact labeling, local training, supervision, and escalation requirements.", "status": "fda_verified", "applicability": "exact_submission", "sourceIds": [ "fda-k241831" ], "lastVerified": "2026-09-04" } }, "prices": { "primary": [], "context": [] }, "sourceRecords": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" }, { "id": "openfda-device-recalls-2026-09-02", "title": "openFDA Device Recall API", "url": "https://open.fda.gov/apis/device/recall/", "publisher": "U.S. Food and Drug Administration" }, { "id": "w29-screenpoint-security", "title": "ScreenPoint Medical Security Reporting", "url": "https://screenpoint-medical.com/security-reporting", "publisher": "ScreenPoint Medical" }, { "id": "phase3-sectra-transpara", "title": "Sectra Amplifier Marketplace: Transpara Breast AI", "url": "https://amplifiermarketplace.sectra.com/application/transpara/", "publisher": "Sectra" } ], "evidenceMetricCount": 4, "readinessPercent": 89, "researchPercent": 100, "researchStatus": "human_reviewed", "oneLineSummary": "Authorized purpose: Transpara 2.1.0 is a concurrent reading aid for physicians interpreting screening full-field digital mammography and digital breast tomosynthesis, providing region and examination scores to support review of suspicious breast findings.", "readerContentStatus": "source_reviewed", "pricingStateLabel": "Not publicly available", "searchTokens": [ "transpara", "2", "1", "0", "screenpoint", "medical", "b", "v", "k241831", "mammography", "dbt", "breast", "regions", "suspicious", "for", "cancer", "on", "screening", "and", "digital", "tomosynthesis", "is", "a", "concurrent", "reading", "aid", "physicians", "interpreting", "full", "field", "providing", "region", "examination", "scores", "to", "support", "review", "of", "findings", "imaging", "authorized", "purpose", "3d", "mammogram" ] } ], "views": [ { "audience": "clinical", "viewLabel": "Clinical", "products": [ { "slug": "mammoscreen-5-k260714", "name": "MammoScreen® (5)", "vendor": "Therapixel", "modality": "Mammography/DBT", "fdaStatus": "FDA-cleared", "submissionNumber": "K260714", "decisionDate": "2026-06-26", "profileHref": "/tools/mammoscreen-5-k260714/#clinical-details" }, { "slug": "transpara-2-1-0-k241831", "name": "Transpara (2.1.0)", "vendor": "ScreenPoint Medical B.V.", "modality": "Mammography/DBT", "fdaStatus": "FDA-cleared", "submissionNumber": "K241831", "decisionDate": "2024-11-25", "profileHref": "/tools/transpara-2-1-0-k241831/#clinical-details" } ], "rows": [ { "key": "anatomy", "label": "Anatomy", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "known", "stateLabel": "Available", "valueText": "Breast", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-05", "sources": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" } ], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "Breast; regions suspicious for cancer on screening mammography and digital breast tomosynthesis", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" } ], "note": null } ] }, { "key": "purpose", "label": "Purpose", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "known", "stateLabel": "Available", "valueText": "Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-05", "sources": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" } ], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "Transpara 2.1.0 is a concurrent reading aid for physicians interpreting screening full-field digital mammography and digital breast tomosynthesis, providing region and examination scores to support review of suspicious breast findings.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" } ], "note": null } ] }, { "key": "workflowRole", "label": "Workflow role", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "known", "stateLabel": "Available", "valueText": "Concurrent reading/reporting aid; includes an initial report populated with selected findings.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-05", "sources": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" } ], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "Concurrent reading aid for screening mammography and DBT interpretation.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" } ], "note": null } ] }, { "key": "input", "label": "Required input", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "known", "stateLabel": "Available", "valueText": "Compatible GE or Hologic FFDM or DBT screening exams, with optional priors; supplementary XCCM, XCCL and ML views are supported in specified scenarios.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-05", "sources": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" } ], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "DICOM full-field digital mammography and digital breast tomosynthesis examinations from compatible systems.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" } ], "note": null } ] }, { "key": "output", "label": "Output and clinician action", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "known", "stateLabel": "Available", "valueText": "Finding-, breast- and case-level scores from 1 to 10, locations and finding marks for masses, asymmetries, distortions and calcifications.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-05", "sources": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" } ], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "DICOM mammography CAD results with marked calcification groups, soft-tissue regions, region scores, and an examination score.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" } ], "note": null } ] }, { "key": "careSetting", "label": "Care setting", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "known", "stateLabel": "Available", "valueText": "Screening mammography workflow.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-05", "sources": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" } ], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "Healthcare facilities performing screening mammography and digital breast tomosynthesis.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" } ], "note": null } ] }, { "key": "intendedUsers", "label": "Intended users", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "known", "stateLabel": "Available", "valueText": "Physicians interpreting screening mammograms.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-05", "sources": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" } ], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "Physicians qualified to interpret screening mammography and digital breast tomosynthesis.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" } ], "note": null } ] }, { "key": "limitations", "label": "Limitations", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "known", "stateLabel": "Available", "valueText": "Not a standalone diagnostic device and not a substitute for physician review; the MammoScreen 5 algorithm is unchanged from MammoScreen 4.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-05", "sources": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" } ], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "The FDA labeling states that the output is not the sole basis for patient management. Use is limited to compatible screening FFDM and DBT and requires physician review; the software does not replace interpretation.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" } ], "note": null } ] }, { "key": "evidenceSummary", "label": "Evidence summary", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "known", "stateLabel": "Available", "valueText": "Regulatory performance evidence is from the prior MammoScreen 3 clinical dataset, not a new MammoScreen 5 clinical study.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-05", "sources": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" } ], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "K241831 FDA decision material reports the exact evidence metrics included below for Transpara 2.1.0; values are limited to the stated endpoint, population, and operating point.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" } ], "note": null } ] } ], "notice": null }, { "audience": "purchasing", "viewLabel": "Pricing & contracts", "products": [ { "slug": "mammoscreen-5-k260714", "name": "MammoScreen® (5)", "vendor": "Therapixel", "modality": "Mammography/DBT", "fdaStatus": "FDA-cleared", "submissionNumber": "K260714", "decisionDate": "2026-06-26", "profileHref": "/tools/mammoscreen-5-k260714/#costs-setup" }, { "slug": "transpara-2-1-0-k241831", "name": "Transpara (2.1.0)", "vendor": "ScreenPoint Medical B.V.", "modality": "Mammography/DBT", "fdaStatus": "FDA-cleared", "submissionNumber": "K241831", "decisionDate": "2024-11-25", "profileHref": "/tools/transpara-2-1-0-k241831/#costs-setup" } ], "rows": [ { "key": "primaryPrice", "label": "Published price", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "not_public", "stateLabel": "Not publicly available", "valueText": null, "scopeText": null, "checkedAt": "2026-09-06", "sources": [], "note": "No public price or contract for MammoScreen 5 was located in the reviewed vendor material." }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "not_public", "stateLabel": "Not publicly available", "valueText": null, "scopeText": null, "checkedAt": "2026-09-04", "sources": [], "note": "No public list price or commercial contract for the exact submission and version was identified." } ] }, { "key": "pricingModel", "label": "Pricing model", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "implementationFees", "label": "Setup and integration fees", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "recurringFees", "label": "Recurring fees", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "minimumCommitment", "label": "Minimum commitment", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "contractTerm", "label": "Contract duration", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "renewalTerms", "label": "Renewal terms", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "terminationTerms", "label": "Cancellation terms", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "supportTerms", "label": "Support and service terms", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "trialTerms", "label": "Trial or pilot terms", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "reimbursement", "label": "Reimbursement", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "not_public", "stateLabel": "Not publicly available", "valueText": null, "scopeText": "Exact FDA submission", "checkedAt": "2026-10-26", "sources": [], "note": "Bounded web search on 2026-10-26 (query: \"Therapixel MammoScreen reimbursement CPT coverage\"; top results reviewed) found no vendor or payer page stating coding, coverage or payment for this product. Therapixel's adoption page describes general US screening mammography policy; it states no coding or payment for this product. This records what was found, not that none exists; eligibility depends on payer, site of service and use case." }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "not_public", "stateLabel": "Not publicly available", "valueText": null, "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [], "note": "No exact-product payer coverage or reimbursement determination was identified in reviewed public material." } ] } ], "notice": "Prices are shown as published for each product, with their own date, unit, currency and scope. They are not directly comparable and are not ranked." }, { "audience": "it", "viewLabel": "IT implementation", "products": [ { "slug": "mammoscreen-5-k260714", "name": "MammoScreen® (5)", "vendor": "Therapixel", "modality": "Mammography/DBT", "fdaStatus": "FDA-cleared", "submissionNumber": "K260714", "decisionDate": "2026-06-26", "profileHref": "/tools/mammoscreen-5-k260714/#it-implementation" }, { "slug": "transpara-2-1-0-k241831", "name": "Transpara (2.1.0)", "vendor": "ScreenPoint Medical B.V.", "modality": "Mammography/DBT", "fdaStatus": "FDA-cleared", "submissionNumber": "K241831", "decisionDate": "2024-11-25", "profileHref": "/tools/transpara-2-1-0-k241831/#it-implementation" } ], "rows": [ { "key": "deployment", "label": "Deployment", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "known", "stateLabel": "Available", "valueText": "Current family documentation describes a site gateway with cloud computation and an on-premises option available on request.", "scopeText": "Product family", "checkedAt": "2026-09-06", "sources": [ { "id": "wave21-worker4-mammoscreen-integration", "title": "MammoScreen integration", "url": "https://www.mammoscreen.com/integration", "publisher": "Therapixel / MammoScreen" } ], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "The FDA package describes a standalone processing appliance with a third-party workstation interface; current hosting, contracts, availability, security, and site configuration remain unknown.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" } ], "note": null } ] }, { "key": "integration", "label": "Integration", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "known", "stateLabel": "Available", "valueText": "Current MammoScreen family documentation describes a site virtual gateway, DICOM Secondary Capture and Structured Report output, and optional EMR/reporting API integration using HL7/FHIR.", "scopeText": "Product family", "checkedAt": "2026-09-06", "sources": [ { "id": "wave21-worker4-mammoscreen-integration", "title": "MammoScreen integration", "url": "https://www.mammoscreen.com/integration", "publisher": "Therapixel / MammoScreen" } ], "note": "Current family documentation, not evidence that every interface or package shipped with the cleared version." }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "The FDA package describes DICOM mammography input and CAD output to a workstation, PACS, or RIS through a standalone processing appliance and third-party workstation interface.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" } ], "note": null } ] }, { "key": "dataLocation", "label": "Data hosting location", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "dataRetention", "label": "Data retention", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "dataUse", "label": "Documented data use", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "hardwareRequirements", "label": "Hardware requirements", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "networkRequirements", "label": "Network requirements", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "identityAccess", "label": "Identity and access", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "security", "label": "Security", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "known", "stateLabel": "Available", "valueText": "Therapixel's own page says Therapixel and its operations for MammoScreen are ISO/IEC 27001 certified by an independent certification body. The page gives no certificate number, scope statement, issue date or expiry, and the certificate was not read.", "scopeText": "Vendor-wide", "checkedAt": "2026-10-25", "sources": [ { "id": "w27-therapixel-iso27001", "title": "Therapixel is now ISO/IEC 27001 certified", "url": "https://www.therapixel.com/therapixel-is-iso27001-certified/", "publisher": "Therapixel" } ], "note": "Vendor-wide statement, not an independent attestation. It does not establish certificate or report scope for this exact release, expiry, data location, retention, identity and access, or incident-response terms for a deployed configuration. Obtain these from the vendor." }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "ScreenPoint Medical's security reporting page states its security program is aligned with ISO/IEC 27001 and describes a vulnerability reporting channel for Transpara. It states alignment, not certification; no controls are listed. Vendor-wide.", "scopeText": "Vendor-wide", "checkedAt": "2026-10-25", "sources": [ { "id": "w29-screenpoint-security", "title": "ScreenPoint Medical Security Reporting", "url": "https://screenpoint-medical.com/security-reporting", "publisher": "ScreenPoint Medical" } ], "note": "Vendor statement, not an attestation; exact-release scope is not established." } ] }, { "key": "implementationTimeline", "label": "Installation timeline", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "missing", "stateLabel": "Not yet reviewed", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": null } ] }, { "key": "training", "label": "Training", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "known", "stateLabel": "Available", "valueText": "The vendor offers a limited-time pilot with remote installation and training.", "scopeText": "Product family", "checkedAt": "2026-09-06", "sources": [ { "id": "wave21-worker4-mammoscreen-pilot", "title": "Try MammoScreen", "url": "https://www.mammoscreen.com/try-mammoscreen", "publisher": "Therapixel / MammoScreen" } ], "note": "Duration, curriculum and applicability to version 5 are not stated." }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "Use by physicians qualified to interpret screening mammography and digital breast tomosynthesis. Follow the exact labeling, local training, supervision, and escalation requirements.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" } ], "note": null } ] }, { "key": "monitoring", "label": "Monitoring", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "state": "unverified", "stateLabel": "Not verified", "valueText": null, "scopeText": "Exact product version", "checkedAt": "2026-09-06", "sources": [], "note": "No site monitoring or update-acceptance procedure was established." }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "state": "known", "stateLabel": "Available", "valueText": "Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K241831.", "scopeText": "Exact FDA submission", "checkedAt": "2026-09-04", "sources": [ { "id": "fda-k241831", "title": "FDA 510(k) decision material K241831: Transpara (2.1.0)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241831.pdf", "publisher": "U.S. Food and Drug Administration" } ], "note": null } ] }, { "key": "compatibility:merge-pacs", "label": "System: Merge PACS", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "compatibilityState": "not_reviewed", "state": "missing", "stateLabel": "Not reviewed for this pairing", "valueText": null, "scopeText": "Scope: product family; geography: Geography not established for this exact pairing", "checkedAt": "2026-11-06", "sources": [ { "id": "phase3-merge-integration-context", "title": "Merge PACS: AI integration and mammography context", "url": "https://www.merge.com/blog/8-requirements-merge-pacs-reliable-imaging", "publisher": "Merge" }, { "id": "system-baseline-merge-pacs-0", "title": "Merge PACS 9.5 DICOM conformance statement", "publisher": "Merge", "url": "https://assets.merative.com/asset/342be38b-cc0c-47cb-88c1-f122edf84d6f/PACS-LBL-0013-Merge-PACS-9-5-DICOM-Conformance-Statement.pdf" }, { "id": "system-baseline-merge-pacs-1", "title": "FDA Z-3004-2026: affected Merge 9.5 ultrasound measurements", "publisher": "FDA", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=221734" } ], "note": "AI version: not established; system version: not established Scope: product family; geography: Geography not established for this exact pairing Configuration: Merge describes mammography integrations including Therapixel. The source does not identify MammoScreen 5 and a specific Merge build. Condition: A supplier-family integration statement is context, not qualification of this FDA record or site installation. Local test needed: Obtain the two exact builds, licensed interface and conformance/acceptance evidence from both suppliers. Source review: 2026-11-06 Broader product-family or vendor context. The exact AI release and system build pairing is not reviewed. Installed-system acceptance has not been performed. Public version baseline: 9.5; Public technical document; reviewed 2026-11-06. Highest version listed in Merge's public DICOM index. Regional availability and corrected patch/build need supplier confirmation. The reviewed FDA record identifies affected 9.5 software. Confirm the supplier's correction and exact build before acceptance. Reference baseline only. Installed build and AI compatibility remain to be established." }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "compatibilityState": "not_reviewed", "state": "missing", "stateLabel": "Not reviewed for this pairing", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [ { "id": "system-baseline-merge-pacs-0", "title": "Merge PACS 9.5 DICOM conformance statement", "publisher": "Merge", "url": "https://assets.merative.com/asset/342be38b-cc0c-47cb-88c1-f122edf84d6f/PACS-LBL-0013-Merge-PACS-9-5-DICOM-Conformance-Statement.pdf" }, { "id": "system-baseline-merge-pacs-1", "title": "FDA Z-3004-2026: affected Merge 9.5 ultrasound measurements", "publisher": "FDA", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=221734" } ], "note": "Obtain the exact AI release and system build before local acceptance. Public version baseline: 9.5; Public technical document; reviewed 2026-11-06. Highest version listed in Merge's public DICOM index. Regional availability and corrected patch/build need supplier confirmation. The reviewed FDA record identifies affected 9.5 software. Confirm the supplier's correction and exact build before acceptance. Reference baseline only. Installed build and AI compatibility remain to be established." } ] }, { "key": "compatibility:visage-7", "label": "System: Visage 7", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "compatibilityState": "not_reviewed", "state": "missing", "stateLabel": "Not reviewed for this pairing", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [ { "id": "system-baseline-visage-7-0", "title": "Visage PathVisions26 announcement, October 15, 2026", "publisher": "Visage Imaging", "url": "https://visageimaging.com/press-release/visage-highlights-one-platform-at-pathvisions26/" } ], "note": "Obtain the exact AI release and system build before local acceptance. Public version baseline: 7.1.21; Announced version; availability unconfirmed; reviewed 2026-11-06. Visage's October 15, 2026 announcement names 7.1.21 for demonstration. General availability and region/build are not established; digital-pathology diagnostic use is described as work in progress. Reference baseline only. Installed build and AI compatibility remain to be established." }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "compatibilityState": "not_reviewed", "state": "missing", "stateLabel": "Not reviewed for this pairing", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [ { "id": "system-baseline-visage-7-0", "title": "Visage PathVisions26 announcement, October 15, 2026", "publisher": "Visage Imaging", "url": "https://visageimaging.com/press-release/visage-highlights-one-platform-at-pathvisions26/" } ], "note": "Obtain the exact AI release and system build before local acceptance. Public version baseline: 7.1.21; Announced version; availability unconfirmed; reviewed 2026-11-06. Visage's October 15, 2026 announcement names 7.1.21 for demonstration. General availability and region/build are not established; digital-pathology diagnostic use is described as work in progress. Reference baseline only. Installed build and AI compatibility remain to be established." } ] }, { "key": "compatibility:sectra-ids7", "label": "System: Sectra IDS7", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "compatibilityState": "not_reviewed", "state": "missing", "stateLabel": "Not reviewed for this pairing", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [ { "id": "system-baseline-sectra-ids7-0", "title": "Sectra IDS7 28.2 public webinar program", "publisher": "Sectra", "url": "https://medical.sectra.com/tisdagstugg-luncha-lar-med-sectra/" }, { "id": "system-baseline-sectra-ids7-1", "title": "Sectra Workstation/Core 28.1 conformance, March 2026", "publisher": "Sectra", "url": "https://medical.sectra.com/wp-content/uploads/sites/3/2026/03/dicom.conformancestatement.sectrapacs-28.1.0.10183.pdf" } ], "note": "Obtain the exact AI release and system build before local acceptance. Public version baseline: 28.2; Announced version; availability unconfirmed; reviewed 2026-11-06. Sectra's public program names IDS7 28.2 for a December 8, 2026 webinar. This establishes an announced version, not general availability or a site build. The public March 2026 conformance statement covers 28.1. Reference baseline only. Installed build and AI compatibility remain to be established." }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "compatibilityState": "not_reviewed", "state": "missing", "stateLabel": "Not reviewed for this pairing", "valueText": null, "scopeText": "Scope: product family; geography: Geography not established for this exact pairing", "checkedAt": "2026-11-06", "sources": [ { "id": "phase3-sectra-transpara", "title": "Sectra Amplifier Marketplace: Transpara Breast AI", "url": "https://amplifiermarketplace.sectra.com/application/transpara/", "publisher": "Sectra" }, { "id": "system-baseline-sectra-ids7-0", "title": "Sectra IDS7 28.2 public webinar program", "publisher": "Sectra", "url": "https://medical.sectra.com/tisdagstugg-luncha-lar-med-sectra/" }, { "id": "system-baseline-sectra-ids7-1", "title": "Sectra Workstation/Core 28.1 conformance, March 2026", "publisher": "Sectra", "url": "https://medical.sectra.com/wp-content/uploads/sites/3/2026/03/dicom.conformancestatement.sectrapacs-28.1.0.10183.pdf" } ], "note": "AI version: not established; system version: not established Scope: product family; geography: Geography not established for this exact pairing Configuration: Sectra lists Transpara results in IDS7, MG CAD SR/SC, overlays and worklist integration. The compatible PACS version must be confirmed. Condition: The marketplace listing does not bind Transpara 2.1.0 in K241831 to a named IDS7 build. Local test needed: Confirm the AI release, IDS7/Core build, licensed integration and region, then test marks, scores, workflow and failure handling. Source review: 2026-11-06 Broader product-family or vendor context. The exact AI release and system build pairing is not reviewed. Installed-system acceptance has not been performed. Public version baseline: 28.2; Announced version; availability unconfirmed; reviewed 2026-11-06. Sectra's public program names IDS7 28.2 for a December 8, 2026 webinar. This establishes an announced version, not general availability or a site build. The public March 2026 conformance statement covers 28.1. Reference baseline only. Installed build and AI compatibility remain to be established." } ] }, { "key": "compatibility:agfa-enterprise-imaging", "label": "System: AGFA Enterprise Imaging", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "compatibilityState": "not_reviewed", "state": "missing", "stateLabel": "Not reviewed for this pairing", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [ { "id": "system-baseline-agfa-enterprise-imaging-0", "title": "AGFA Enterprise Imaging IHE statement, revision 12", "publisher": "AGFA HealthCare", "url": "https://www.agfahealthcare.com/wp-content/uploads/2026/01/001685_Enterprise_Imaging_8.4.x_IHE_Integration_Statement.pdf" } ], "note": "Obtain the exact AI release and system build before local acceptance. Public version baseline: 8.4.4; Public technical document; reviewed 2026-11-06. AGFA's current public IHE statement, revision 12, names 8.4.4 (October 2025). Exact service build, regional availability and newer private releases need supplier confirmation. Reference baseline only. Installed build and AI compatibility remain to be established." }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "compatibilityState": "not_reviewed", "state": "missing", "stateLabel": "Not reviewed for this pairing", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [ { "id": "system-baseline-agfa-enterprise-imaging-0", "title": "AGFA Enterprise Imaging IHE statement, revision 12", "publisher": "AGFA HealthCare", "url": "https://www.agfahealthcare.com/wp-content/uploads/2026/01/001685_Enterprise_Imaging_8.4.x_IHE_Integration_Statement.pdf" } ], "note": "Obtain the exact AI release and system build before local acceptance. Public version baseline: 8.4.4; Public technical document; reviewed 2026-11-06. AGFA's current public IHE statement, revision 12, names 8.4.4 (October 2025). Exact service build, regional availability and newer private releases need supplier confirmation. Reference baseline only. Installed build and AI compatibility remain to be established." } ] }, { "key": "compatibility:intelepacs", "label": "System: IntelePACS", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "compatibilityState": "not_reviewed", "state": "missing", "stateLabel": "Not reviewed for this pairing", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [ { "id": "system-baseline-intelepacs-0", "title": "FDA IntelePACS record identifying 5.9.1", "publisher": "FDA", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222843" } ], "note": "Obtain the exact AI release and system build before local acceptance. Public version baseline: 5.9.1; Regulatory identification; corrected build unconfirmed; reviewed 2026-11-06. The October 2026 FDA record identifies IntelePACS 5.9.1 among affected portal releases. This is the highest public release found, not evidence of the latest corrected patch or general availability. The record concerns portal report/image matching with specified Chromium browsers. Confirm the corrected portal build and browser configuration with the supplier. Reference baseline only. Installed build and AI compatibility remain to be established." }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "compatibilityState": "not_reviewed", "state": "missing", "stateLabel": "Not reviewed for this pairing", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [ { "id": "system-baseline-intelepacs-0", "title": "FDA IntelePACS record identifying 5.9.1", "publisher": "FDA", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222843" } ], "note": "Obtain the exact AI release and system build before local acceptance. Public version baseline: 5.9.1; Regulatory identification; corrected build unconfirmed; reviewed 2026-11-06. The October 2026 FDA record identifies IntelePACS 5.9.1 among affected portal releases. This is the highest public release found, not evidence of the latest corrected patch or general availability. The record concerns portal report/image matching with specified Chromium browsers. Confirm the corrected portal build and browser configuration with the supplier. Reference baseline only. Installed build and AI compatibility remain to be established." } ] }, { "key": "compatibility:ge-mammography-input", "label": "System: GE FFDM/DBT input", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "compatibilityState": "conditional_support", "state": "known", "stateLabel": "Conditional support", "valueText": "Conditional support. AI version: MammoScreen 5; system version: not established", "scopeText": "Scope: exact submission; geography: United States labeling", "checkedAt": "2026-11-06", "sources": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" } ], "note": "Configuration: FDA-labeled FFDM/DBT input from compatible GE equipment; a software build is not identified. Condition: Confirm the precise acquisition model, software, priors and supported scenarios against the release-specific labeling. Local test needed: Route representative labeled exams and verify study identity, findings, reporting and fallback review. Source review: 2026-11-06 Source documentation describes this scope; local installed-system acceptance remains open. Installed-system acceptance has not been performed." }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "compatibilityState": "not_reviewed", "state": "missing", "stateLabel": "Not reviewed for this pairing", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": "Obtain the exact AI release and system build before local acceptance." } ] }, { "key": "compatibility:hologic-mammography-input", "label": "System: Hologic FFDM/DBT input", "cells": [ { "slug": "mammoscreen-5-k260714", "productName": "MammoScreen® (5)", "compatibilityState": "conditional_support", "state": "known", "stateLabel": "Conditional support", "valueText": "Conditional support. AI version: MammoScreen 5; system version: not established", "scopeText": "Scope: exact submission; geography: United States labeling", "checkedAt": "2026-11-06", "sources": [ { "id": "wave21-worker4-fda-k260714", "title": "MammoScreen 5: K260714 clearance and 510(k) summary", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260714.pdf", "publisher": "US Food and Drug Administration" } ], "note": "Configuration: FDA-labeled FFDM/DBT input from compatible Hologic equipment; a software build is not identified. Condition: Confirm the precise acquisition model, software and current/prior image scenarios; do not extend the claim to every Hologic configuration. Local test needed: Test the agreed inputs and exclusions, findings, initial report and retained physician review. Source review: 2026-11-06 Source documentation describes this scope; local installed-system acceptance remains open. Installed-system acceptance has not been performed." }, { "slug": "transpara-2-1-0-k241831", "productName": "Transpara (2.1.0)", "compatibilityState": "not_reviewed", "state": "missing", "stateLabel": "Not reviewed for this pairing", "valueText": null, "scopeText": null, "checkedAt": null, "sources": [], "note": "Obtain the exact AI release and system build before local acceptance." } ] } ], "notice": "Source relationships retain their version, scope and conditions. They do not establish acceptance of your installed system." } ], "baselines": [ { "systemId": "merge-pacs", "name": "Merge PACS", "lines": [ "Public version baseline: 9.5; Public technical document; reviewed 2026-11-06.", "Highest version listed in Merge's public DICOM index. Regional availability and corrected patch/build need supplier confirmation.", "The reviewed FDA record identifies affected 9.5 software. Confirm the supplier's correction and exact build before acceptance.", "Reference baseline only. Installed build and AI compatibility remain to be established." ], "sources": [ { "title": "Merge PACS 9.5 DICOM conformance statement", "url": "https://assets.merative.com/asset/342be38b-cc0c-47cb-88c1-f122edf84d6f/PACS-LBL-0013-Merge-PACS-9-5-DICOM-Conformance-Statement.pdf" }, { "title": "FDA Z-3004-2026: affected Merge 9.5 ultrasound measurements", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=221734" } ] }, { "systemId": "visage-7", "name": "Visage 7", "lines": [ "Public version baseline: 7.1.21; Announced version; availability unconfirmed; reviewed 2026-11-06.", "Visage's October 15, 2026 announcement names 7.1.21 for demonstration. General availability and region/build are not established; digital-pathology diagnostic use is described as work in progress.", "Reference baseline only. Installed build and AI compatibility remain to be established." ], "sources": [ { "title": "Visage PathVisions26 announcement, October 15, 2026", "url": "https://visageimaging.com/press-release/visage-highlights-one-platform-at-pathvisions26/" } ] }, { "systemId": "sectra-ids7", "name": "Sectra IDS7", "lines": [ "Public version baseline: 28.2; Announced version; availability unconfirmed; reviewed 2026-11-06.", "Sectra's public program names IDS7 28.2 for a December 8, 2026 webinar. This establishes an announced version, not general availability or a site build. The public March 2026 conformance statement covers 28.1.", "Reference baseline only. Installed build and AI compatibility remain to be established." ], "sources": [ { "title": "Sectra IDS7 28.2 public webinar program", "url": "https://medical.sectra.com/tisdagstugg-luncha-lar-med-sectra/" }, { "title": "Sectra Workstation/Core 28.1 conformance, March 2026", "url": "https://medical.sectra.com/wp-content/uploads/sites/3/2026/03/dicom.conformancestatement.sectrapacs-28.1.0.10183.pdf" } ] }, { "systemId": "agfa-enterprise-imaging", "name": "AGFA Enterprise Imaging", "lines": [ "Public version baseline: 8.4.4; Public technical document; reviewed 2026-11-06.", "AGFA's current public IHE statement, revision 12, names 8.4.4 (October 2025). Exact service build, regional availability and newer private releases need supplier confirmation.", "Reference baseline only. Installed build and AI compatibility remain to be established." ], "sources": [ { "title": "AGFA Enterprise Imaging IHE statement, revision 12", "url": "https://www.agfahealthcare.com/wp-content/uploads/2026/01/001685_Enterprise_Imaging_8.4.x_IHE_Integration_Statement.pdf" } ] }, { "systemId": "intelepacs", "name": "IntelePACS", "lines": [ "Public version baseline: 5.9.1; Regulatory identification; corrected build unconfirmed; reviewed 2026-11-06.", "The October 2026 FDA record identifies IntelePACS 5.9.1 among affected portal releases. This is the highest public release found, not evidence of the latest corrected patch or general availability.", "The record concerns portal report/image matching with specified Chromium browsers. Confirm the corrected portal build and browser configuration with the supplier.", "Reference baseline only. Installed build and AI compatibility remain to be established." ], "sources": [ { "title": "FDA IntelePACS record identifying 5.9.1", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222843" } ] } ], "privateQuotes": [ { "schemaVersion": 1, "recordType": "buyer_entered_procurement_quote", "identity": { "slug": "mammoscreen-5-k260714", "submissionNumber": "K260714" }, "savedAt": null, "values": { "module": "FICTIONAL scope placeholder, not a supplier offer", "version": "FICTIONAL release, not mapped to the FDA record", "country": "", "currency": "", "quoteDate": "", "validUntil": "", "offerScope": "", "volumeBasis": "", "minimumCommitment": "", "supportTerms": "", "upgradeTerms": "", "renewalTerms": "", "terminationTerms": "", "exitTerms": "", "conflictNote": "" }, "costs": { "license": { "status": "unknown", "amount": "", "unit": "", "note": "" }, "setup": { "status": "unknown", "amount": "", "unit": "", "note": "" }, "interfaces": { "status": "unknown", "amount": "", "unit": "", "note": "" }, "hardware": { "status": "unknown", "amount": "", "unit": "", "note": "" }, "recurring": { "status": "unknown", "amount": "", "unit": "", "note": "" }, "support": { "status": "unknown", "amount": "", "unit": "", "note": "" }, "upgrades": { "status": "unknown", "amount": "", "unit": "", "note": "" }, "exit": { "status": "unknown", "amount": "", "unit": "", "note": "" } }, "applicability": "not_stated", "conflict": "not_checked" } ], "quoteAssessments": [ { "slug": "mammoscreen-5-k260714", "attached": true, "assessment": { "missing": [ "Country or market", "Currency", "Quote date", "Bundle and exclusions", "Volume and pricing basis", "Minimum commitment", "Support terms", "Upgrade terms", "Renewal terms", "Termination terms", "Exit and data handoff", "Exact offer applicability", "Quote/contract conflict check", "Base license: confirm whether charged, included or not applicable", "Setup and implementation: confirm whether charged, included or not applicable", "Interfaces and gateways: confirm whether charged, included or not applicable", "Hardware and compute: confirm whether charged, included or not applicable", "Other recurring costs: confirm whether charged, included or not applicable", "Support charges: confirm whether charged, included or not applicable", "Upgrade charges: confirm whether charged, included or not applicable", "Exit and migration charges: confirm whether charged, included or not applicable" ], "invalid": [], "conflict": false, "expired": false, "readyForReview": false } }, { "slug": "transpara-2-1-0-k241831", "attached": false, "assessment": { "missing": [ "Offered module", "Offered software version", "Country or market", "Currency", "Quote date", "Bundle and exclusions", "Volume and pricing basis", "Minimum commitment", "Support terms", "Upgrade terms", "Renewal terms", "Termination terms", "Exit and data handoff", "Exact offer applicability", "Quote/contract conflict check", "Base license: confirm whether charged, included or not applicable", "Setup and implementation: confirm whether charged, included or not applicable", "Interfaces and gateways: confirm whether charged, included or not applicable", "Hardware and compute: confirm whether charged, included or not applicable", "Other recurring costs: confirm whether charged, included or not applicable", "Support charges: confirm whether charged, included or not applicable", "Upgrade charges: confirm whether charged, included or not applicable", "Exit and migration charges: confirm whether charged, included or not applicable" ], "invalid": [], "conflict": false, "expired": false, "readyForReview": false } } ], "scenario": { "relationNote": "FICTIONAL facility example of the appendix format only. This scenario is not mapped to either selected FDA record and establishes no product-specific performance or price.", "snapshot": { "snapshotVersion": 1, "exportedAt": "2026-11-09T02:26:30.977Z", "interpretation": "User assumptions, not confidence intervals, verified prices or guaranteed savings.", "inputs": { "schemaVersion": 1, "calculationVersion": "interpretation-capacity-v1", "recordType": "private_capacity_cost_scenario", "workflow": "interpretation_support", "savedAt": null, "scope": { "module": "FICTIONAL interpretation workflow", "version": "FICTIONAL 1", "currency": "USD", "benefitBasis": "FICTIONAL demand and staffing assumptions for the sample appendix only; not measured for either selected product.", "costBasis": "FICTIONAL complete one-time and annual costs; no product price is asserted." }, "mechanism": "additional_exams", "costsComplete": true, "common": { "annualVolume": { "value": "12000", "origin": "buyer_entered", "reference": "" }, "baselineSeconds": { "value": "600", "origin": "buyer_entered", "reference": "" }, "oneTimeCosts": { "value": "1000", "origin": "buyer_entered", "reference": "" }, "recurringCosts": { "value": "1000", "origin": "buyer_entered", "reference": "" }, "operatingCosts": { "value": "500", "origin": "buyer_entered", "reference": "" }, "cashSharePercent": { "value": "", "origin": "buyer_entered", "reference": "" }, "avoidableExpense": { "value": "", "origin": "buyer_entered", "reference": "" }, "expenseHoursRequired": { "value": "", "origin": "buyer_entered", "reference": "" }, "incrementalDemand": { "value": "250", "origin": "buyer_entered", "reference": "" }, "examsPerHour": { "value": "4", "origin": "buyer_entered", "reference": "" }, "scannerCapacity": { "value": "180", "origin": "buyer_entered", "reference": "" }, "downstreamCapacity": { "value": "120", "origin": "buyer_entered", "reference": "" }, "contributionMargin": { "value": "25", "origin": "buyer_entered", "reference": "" } }, "cases": { "low": { "grossSecondsSaved": { "value": "30", "origin": "buyer_entered", "reference": "" }, "reworkSeconds": { "value": "30", "origin": "buyer_entered", "reference": "" }, "adoptionPercent": { "value": "50", "origin": "buyer_entered", "reference": "" } }, "base": { "grossSecondsSaved": { "value": "90", "origin": "buyer_entered", "reference": "" }, "reworkSeconds": { "value": "30", "origin": "buyer_entered", "reference": "" }, "adoptionPercent": { "value": "50", "origin": "buyer_entered", "reference": "" } }, "high": { "grossSecondsSaved": { "value": "150", "origin": "buyer_entered", "reference": "" }, "reworkSeconds": { "value": "30", "origin": "buyer_entered", "reference": "" }, "adoptionPercent": { "value": "75", "origin": "buyer_entered", "reference": "" } } } }, "calculated": { "calculationVersion": "interpretation-capacity-v1", "results": { "low": { "capacityHours": 0, "cashAllocatedHours": 0, "examAllocatedHours": 0, "additionalExams": 0, "avoidableExpense": 0, "annualCashBenefit": 0, "annualNetBenefit": -1500, "firstYearNet": -2500, "firstYearRoiPercent": -100, "paybackMonths": null, "warnings": [ "Payback unavailable: annual net cash benefit is not positive." ] }, "base": { "capacityHours": 100, "cashAllocatedHours": 0, "examAllocatedHours": 100, "additionalExams": 120, "avoidableExpense": 0, "annualCashBenefit": 3000, "annualNetBenefit": 1500, "firstYearNet": 500, "firstYearRoiPercent": 20, "paybackMonths": 8, "warnings": [] }, "high": { "capacityHours": 300, "cashAllocatedHours": 0, "examAllocatedHours": 300, "additionalExams": 120, "avoidableExpense": 0, "annualCashBenefit": 3000, "annualNetBenefit": 1500, "firstYearNet": 500, "firstYearRoiPercent": 20, "paybackMonths": 8, "warnings": [] } }, "firstYearCost": 2500, "zeroCashBenefitFirstYearNet": -2500, "costWarnings": [] }, "formulas": [ "Net seconds saved/exam = gross seconds saved − additional rework seconds.", "Annual capacity hours = eligible annual exams × net seconds saved/exam × adoption percent / 100 / 3600. Negative hours mean added workload.", "Positive hours = max(0, capacity hours). Allocate all to the chosen cash path, or partition by the stated percent. Capacity-only hours have no cash value assigned.", "Avoidable cash expense = target expense only when allocated cash hours ≥ required annual hours; otherwise 0. Reserved cash hours cannot also support extra exams.", "Additional completed exams = floor(max(0, min(unmet annual demand, allocated exam hours × feasible exams/hour, available scanner slots, staffing/downstream capacity))).", "Annual cash benefit = avoidable cash expense + additional completed exams × contribution margin/exam.", "Annual net benefit = annual cash benefit − annual recurring supplier costs − annual additional operating costs.", "First-year net = annual net benefit − one-time implementation/capital costs. First-year ROI percent = first-year net / complete first-year costs × 100, only if costs > 0.", "Simple payback months = one-time costs / (positive annual net benefit / 12). It assumes steady annual cash flow, with no discounting, tax, financing or ramp-up model.", "Zero cash-benefit check: first-year net = −(one-time + annual recurring + annual operating costs). It assumes no realized cash benefit, even if capacity improves." ] } }, "decisions": [ "Confirm the offered module, exact AI build, market authorization and population against each selected FDA record.", "Agree the clinical question, matched evaluation cases, exclusions, endpoints and clinician action. Different studies or products are not assumed equivalent.", "Obtain exact installed PACS/viewer and interface builds, supplier evidence and local acceptance results. Public reference versions do not qualify a pairing.", "Resolve every missing, conflicting, withdrawn or broader-scope fact and every quote gap before a purchasing decision.", "Validate the scenario's workload, adoption, rework, demand, removable payments, cost scope and hour allocations with operations and purchasing.", "Name clinical, IT and purchasing owners, acceptance authority, monitoring, change control, stop-use criteria and rollback. No acceptance or purchase approval is recorded by this packet." ], "fingerprint": "321451eaf51f82d12cef6374721d88a8021bbbe496d23726d68d3c20e3a98415" }