Supported acquisition environment
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
FDA-cleared profile
Transpara 1.7.2
ScreenPoint Medical B.V.
Authorized purpose: Concurrent reading aid for physicians interpreting screening FFDM/DBT to identify suspicious breast regions and estimate malignancy likelihood.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Concurrent reading aid for physicians interpreting screening FFDM/DBT to identify suspicious breast regions and estimate malignancy likelihood.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Concurrent reading aid for physicians interpreting screening FFDM/DBT to identify suspicious breast regions and estimate malignancy likelihood.
- Which images or clinical context are in scope? Modality: Mammography/DBT Anatomy or clinical context: Breast Input: Compatible screening full-field digital mammography and digital breast tomosynthesis exams in DICOM.
- Who uses it? Intended users: Physicians qualified to read screening mammography and digital breast tomosynthesis exams.
- What does the software produce? Output: CAD marks for suspicious calcifications or soft-tissue lesions, 0-100 region scores, corresponding-region links, and a 1-10 exam score.
- What is its most important limitation? Key limitation: Adjunctive concurrent aid only; patient-management decisions must not rely solely on the device; intended population is women undergoing screening mammography/DBT.
Clinical takeaway
Clinical role: Concurrent reading aid for physicians interpreting screening FFDM/DBT to identify suspicious breast regions and estimate malignancy likelihood.
Evidence takeaway
Evidence from the reviewed source record: FDA reports 10,690 exams: FFDM sensitivity 95.0% (93.5-96.4) at 0.30 FP/image, DBT sensitivity 93.2% (91.0-95.1) at 0.34 FP/volume, and AUC 0.945 for each; specificity is not reported.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Concurrent reading aid for physicians interpreting screening FFDM/DBT to identify suspicious breast regions and estimate malignancy likelihood.
Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.
- Intended users
- Physicians qualified to read screening mammography and digital breast tomosynthesis exams.
FDA intended-user statement.
- Care setting and population
- The screening population described in the FDA intended use; the institutional care setting requires local confirmation.
Conservative normalization of explicit wording in an exact-submission source.
- Workflow role
- Measurement or quantification
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- Compatible screening full-field digital mammography and digital breast tomosynthesis exams in DICOM.
FDA input scope.
- Output and human action
- CAD marks for suspicious calcifications or soft-tissue lesions, 0-100 region scores, corresponding-region links, and a 1-10 exam score.
FDA output description.
- Limitations
- Adjunctive concurrent aid only; patient-management decisions must not rely solely on the device; intended population is women undergoing screening mammography/DBT.
Exact FDA limitation and population boundary.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
- Deployment and data flow
- On-premise
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Transpara 1.7.2; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
- Evidence summary
- FDA reports 10,690 exams: FFDM sensitivity 95.0% (93.5-96.4) at 0.30 FP/image, DBT sensitivity 93.2% (91.0-95.1) at 0.34 FP/volume, and AUC 0.945 for each; specificity is not reported.
Submission-reported FDA standalone evidence summary.
- Reported sensitivity
- 2D: 95.0% (93.5-96.4) at 0.30 FP/image DBT: 93.2% (91.0-95.1) at 0.34 FP/volume
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Transpara 1.7.2 regulatory performance study summary
- DesignStand-Alone Performance
- PopulationPopulation described in the exact-submission ACR model card
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K221347
- Samplen=10690
- Sites7
- IndependenceIndependence not established
K221347
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Vendor documentation pending
No public price or quote for the exact K221347 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- The exact-identifier FDA recall query returned no native recall record for K221347. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K221347 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
26Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, fda decision summary packet, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history
Source ledger
-
FDA K221347: Transpara 1.7.2
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Transpara 1.7.2 model card (K221347)
Scope: intendedUsers, output, limitations, reportedSensitivity, evidenceSummary, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K221347
Scope: postmarketSafety
Research history
-
K221347 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
Alternatives
Related tools to compare
FDA-cleared K260714
MammoScreen® (5)
Therapixel
Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2026-06-26
FDA-cleared K253825
Saige-Dx
DeepHealth, Inc.
Concurrent detection and characterization support for screening DBT mammography
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2026-06-15
FDA-cleared K252954
MammoSightAI
Neurocareai, Inc. (Dba Savelife.Ai)
Tags screening cases as suspicious or blank to aid worklist prioritization; radiologists must review every examination and it does not mark original images.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2026-05-04
FDA-cleared K260320
Lunit INSIGHT MMG (v1.1.10)
Lunit, Inc.
Lunit INSIGHT MMG v1.1.10 aids physicians in detection, localization and characterization of suspicious breast-cancer areas on female screening mammograms from compatible FFDM...
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2026-04-23