Saige-Dx analyzes screening DBT stacks and associated full-field digital or synthetic 2D mammograms, assigning finding and case suspicion levels to support qualified interpreting physicians; it does not replace their review or clinical judgment.
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
Saige-Dx analyzes screening DBT stacks and associated full-field digital or synthetic 2D mammograms, assigning finding and case suspicion levels to support qualified interpreting physicians; it does not replace their review or clinical judgment.
FDA source Exact FDA submission Checked 2026-09-05
Finding bounding boxes and finding/case suspicion levels, packaged in DICOM Structured Report and Secondary Capture summary objects and routed to PACS or another worklist.
FDA source Exact FDA submission Checked 2026-09-05
Outputs are adjunctive and must not be the sole basis for patient-management decisions; the device does not replace review of the complete mammography examination.
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
K251873
FDA source Exact FDA submission Checked 2026-08-31
Public source Exact FDA submission Checked 2026-08-13
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
Vendor confirmation Exact FDA submission Checked 2026-09-06
No dated, scoped security attestation was reviewed.
Training and support
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
Current training and support commitments were not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Current branded compatibility context
DeepHealth identifies SmartMammo Dx as Saige DX and describes GE Senographe Pristina compatibility for that branded offering.
product family · checked 2026-09-05
Do not infer all SmartMammo suite functions or current compatibility terms for K251873.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
A retrospective blinded multicenter standalone assessment used 2,002 unique women from 12 U.S. sites (259 cancer and 1,743 noncancer cases); the primary noninferiority comparison with the predicate met its acceptance criterion.
FDA source Exact FDA submission Checked 2026-09-05
No release-specific sensitivity or specificity was abstracted from the reviewed FDA text.
Reviewed sources checked Exact FDA submission Checked 2026-09-05
A numerical sensitivity with complete endpoint context was not established in the reviewed material.
Reported specificity
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-05
A numerical specificity with complete endpoint context was not established in the reviewed material.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Saige-Dx regulatory standalone assessment
Retrospective blinded multicenter standalone assessment · 2,002 unique U.S. screening participants; 259 cancer and 1,743 noncancer cases
exact submission · Tested version: Saige-Dx submitted in K251873; build not stated · n=2002 · 12 sites · Independence not established
K251873
Primary endpoint was noninferiority to the predicate; the reviewed summary did not provide a complete numeric sensitivity/specificity table.
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
No scoped public price or procurement award was reviewed; commercial terms require quotation.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-06
No applicable payer policy was reviewed; mammography reimbursement does not establish separate software payment.
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 security and privacy controls: No dated, scoped security attestation was reviewed.
Verify training: Current training and support commitments were not established.
Verify pricing and total cost: No scoped public price or procurement award was reviewed; commercial terms require quotation.
Verify reimbursement and coding relevance: No applicable payer policy was reviewed; mammography reimbursement does not establish separate software payment.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
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
2026-09-05Last searched
24Fields reviewed
11Source classes checked
1Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
Stored PubMed metadata was screened. PMID 40983310 is a Saige-Dx family microsimulation model and is retained as contextual evidence only; it is not product pricing or real-world performance. No stored trial candidates. 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, fda decision summary, acr ai central product, fda decision material, vendor product page, literature index, trial registry, fda device recall, pubmed, clinical trials, openfda device recall
Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.
Tags screening cases as suspicious or blank to aid worklist prioritization; radiologists must review every examination and it does not mark original images.
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