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
Concurrent detection and characterization support for screening DBT mammography
FDA source Exact FDA submission Checked 2026-09-05
DICOM DBT image stacks and associated FFDM and/or synthetic 2D images from compatible Hologic, GE and Siemens systems; prior-exam processing evaluated for Hologic and GE
FDA source Exact FDA submission Checked 2026-09-05
Adjunct concurrent interpretation only; physician review remains required. Siemens compatibility and prior-exam processing have distinct validation cohorts and must not be assumed interchangeable across acquisition systems.
FDA source Exact FDA submission Checked 2026-09-05
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
FDA submission
K253825
FDA source Exact FDA submission Checked 2026-08-31
Vendor confirmation Exact FDA submission Checked 2026-09-05
Exact hosting topology, hardware requirements and contracted PACS integration were not established.
Security and privacy
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-05
No scoped dated attestation for the Saige-Dx deployment was reviewed.
Training and support
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-05
Site training, suspicion-score interpretation curriculum and competency assessment remain unestablished.
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-05
Post-deployment false-positive/false-negative auditing and update-specific acceptance requirements remain to be confirmed.
Vendor product-family identity
DeepHealth identifies SmartMammo Dx as also known as Saige DX within the multi-component SmartMammo offering
product family · checked 2026-09-06
The 2024 announcement predates K253825; other SmartMammo components and later rebranded products are not automatically capabilities of this submission.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
Two retrospective blinded standalone studies: 2,425 DBT cases (509 Siemens, 514 GE, 1,402 Hologic) and 684 current/prior patients from Hologic and GE. The summary reports successful noninferiority endpoints without usable sensitivity/specificity point estimates.
FDA source Exact FDA submission Checked 2026-09-05
Reviewed sources checked Exact FDA submission Checked 2026-09-05
Submission summary describes noninferiority but does not report a usable exact-version sensitivity estimate with operating point.
Reported specificity
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-05
Exact-version specificity point estimate and operating point were not established in the reviewed summary.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K253825 acquisition-system standalone validation
Retrospective blinded standalone noninferiority evaluation · 509 Siemens, 514 GE and 1,402 Hologic DBT cases
exact submission · Tested version: Saige-Dx in K253825; release number not established · n=2425 · Independence not established
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
A published family economic model references a consumer screening add-on charge. This does not establish K253825 procurement cost, a current quote or a software-only price.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-05
No applicable payer policy was reviewed; cost-effectiveness modeling is not reimbursement evidence.
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
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify deployment and data flow: Exact hosting topology, hardware requirements and contracted PACS integration were not established.
Verify security and privacy controls: No scoped dated attestation for the Saige-Dx deployment was reviewed.
Verify training: Site training, suspicion-score interpretation curriculum and competency assessment remain unestablished.
Verify pricing and total cost: A published family economic model references a consumer screening add-on charge. This does not establish K253825 procurement cost, a current quote or a software-only price.
Verify reimbursement and coding relevance: No applicable payer policy was reviewed; cost-effectiveness modeling is not reimbursement evidence.
Verify local validation and lifecycle monitoring: Post-deployment false-positive/false-negative auditing and update-specific acceptance requirements remain to be confirmed.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-06Last searched
18Fields reviewed
11Source classes checked
1Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
Stored PubMed candidate reviewed and retained as contextual family economic modeling; no exact-version outcomes or payer coverage promoted. Stored clinical-trial candidate array is empty. The current discovery snapshot contains 1 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, acr ai central product, fda decision summary, vendor product page, literature index, peer reviewed publication, trial registry, recall database, pubmed, clinical trials, openfda device recall
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