Release and scope verification
Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to K241831.
exact submission · checked 2026-09-04FDA-cleared profile
Transpara (2.1.0)
ScreenPoint Medical B.V.
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.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact 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.
- Intended users
- Physicians qualified to interpret screening mammography and digital breast tomosynthesis.
- Care setting and population
- Healthcare facilities performing screening mammography and digital breast tomosynthesis.
- Workflow role
- Concurrent reading aid for screening mammography and DBT interpretation.
- Required input
- DICOM full-field digital mammography and digital breast tomosynthesis examinations from compatible systems.
- Output and human action
- DICOM mammography CAD results with marked calcification groups, soft-tissue regions, region scores, and an examination score.
- Limitations
- 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.
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
- 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.
- Deployment and data flow
- The FDA package describes a standalone processing appliance with a third-party workstation interface; current hosting, contracts, availability, security, and site configuration remain unknown.
- Security and privacy
- Not established in reviewed sources
Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
- Training and support
- Use by physicians qualified to interpret screening mammography and digital breast tomosynthesis. Follow the exact labeling, local training, supervision, and escalation requirements.
- Monitoring and change control
- Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K241831.
Deployment boundary
The FDA package describes a standalone processing appliance with a third-party workstation interface; current hosting, contracts, availability, security, and site configuration remain unknown.
exact submission · checked 2026-09-04Interoperability acceptance
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.
exact submission · checked 2026-09-04Clinical acceptance
Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for K241831.
exact submission · checked 2026-09-04Economic evaluation
Exact-product price, implementation cost, reimbursement, and total-cost evidence remain to be obtained; do not infer them from FDA clearance.
product family · checked 2026-09-04Lifecycle monitoring
Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.
exact submission · checked 2026-09-04Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- 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.
- Reported sensitivity
- 70%; 80%; 97%
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
- Reported specificity
- 70%; 80%; 97%
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
FFDM sensitivity at 70% specificity
97.4 percentSensitivity at the FDA-reported operating point in FFDM screening examinations with biopsy-proven cancer cases.
Tested version: Transpara 2.1.0DBT sensitivity at 70% specificity
96.9 percentSensitivity at the FDA-reported operating point in DBT screening examinations with biopsy-proven cancer cases.
Tested version: Transpara 2.1.0FFDM exam-based AUC
0.96 AUCExam-based discrimination in FFDM screening examinations.
Tested version: Transpara 2.1.0DBT exam-based AUC
0.955 AUCExam-based discrimination in DBT screening examinations.
Tested version: Transpara 2.1.0K241831 FDA evidence package for Transpara (2.1.0)
FDA 510(k) standalone performance evaluation of FFDM and DBT screening examinations. · 10,207 examinations including 1,350 biopsy-proven cancers; FFDM and DBT cohorts from seven European countries and the United States.
exact submission · Tested version: Transpara 2.1.0 · n=10207 · Sponsor or vendor studyK241831
FDA-reported results for the exact Transpara 2.1.0 submission.
Performance across different versions of an artificial intelligence model for screen-reading of mammograms
Retrospective multicenter registry cohort comparing Transpara versions 1.7 and 2.1. · 117,709 screening examinations including 737 screen-detected and 200 interval cancers from two breast centers.
exact product version · Tested version: Transpara 2.1 · n=117709 · 2 sites · Independence not establishedPMID:41528472
The PubMed record explicitly identifies Transpara version 2.1. The article reports the major-minor release label; no broader Transpara-family claim is promoted.
Economics and lifecycle
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Not established in reviewed sources
No public list price or commercial contract for the exact submission and version was identified.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
No product-specific code
No exact-product reimbursement determination identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesThis public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value assumptions independently.
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
- No record matched K241831 by exact native submission identifier in the 2026-09-02 openFDA snapshot; this does not exclude product-family, later-version, or adverse-event information.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
- Verify pricing and total cost: No public list price or commercial contract for the exact submission and version was identified.
- Verify reimbursement and coding relevance: No exact-product payer coverage or reimbursement determination was identified in reviewed public material.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-04Last searched
27Fields reviewed
11Source classes checked
18Reviewed PubMed leads
6Reviewed trial leads
0Unreviewed FDA recall leads
Promoted PMID 41528472 because its record explicitly tests Transpara version 2.1. The other 17 PubMed records and all 6 trial records were quarantined because they are unrelated, unversioned, or test Transpara 1.6, 1.7, 1.7.1, 1.7.3, or 2.0.0 rather than the exact 2.1 release. The current discovery snapshot contains 18 PubMed and 6 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 decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-04.
- FDA 510(k) decision material K241831: Transpara (2.1.0) U.S. Food and Drug Administration · 2026-09-04
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- Transpara (2.1.0) model card (K241831) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
- Performance across different versions of an artificial intelligence model for screen-reading of mammograms European Radiology via PubMed · 2026-09-04
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