MammoScreen® (4)

Evidence summary

Standalone comparison used 1,475 patients and 2,950 paired DBT studies; the regulatory summary reports AUC and localization endpoints for this specific compatibility evaluation.

FDA source Exact FDA submission Checked 2026-09-05

• Source

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.

• Verify security and privacy controls: No dated, scoped security evidence was reviewed.
• Verify pricing and total cost: No public price was located in reviewed vendor material.
• Verify reimbursement and coding relevance: No applicable payer policy was reviewed.
• 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.

Stored PMID 32159424 is an online breast-cancer risk decision-aid study, not MammoScreen evidence; excluded by metadata. No trial records stored. 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, vendor technical page, vendor product page, literature index, trial registry, pubmed, clinical trials, openfda device recall

• K243679 FDA decision source U.S. Food and Drug Administration · 2026-08-31
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• MammoScreen 4 model card (K243679) 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
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• MammoScreen integration Therapixel / MammoScreen · 2026-09-06
• Try MammoScreen Therapixel / MammoScreen · 2026-09-06
• MammoScreen 4: K243679 clearance and 510(k) summary US Food and Drug Administration · 2026-09-05