DEEPVESSEL Plaque

Evidence summary

Standalone study used 147 CCTA cases from three US sites with three-expert consensus reference; it did not use IVUS or histology as reference.

FDA source Exact FDA submission Checked 2026-09-05

• Source

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

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 deployment and data flow: Hosting region, retention, supported PACS interfaces and purchased configuration were not established.
• Verify security and privacy controls: No dated, scoped security attestation reviewed.
• Verify training: Analyst credentialing, correction workflow and cardiologist review protocol require confirmation.
• Verify pricing and total cost: No public exact-version rate or procurement award reviewed.
• Verify reimbursement and coding relevance: No applicable payer policy reviewed.
• Verify local validation and lifecycle monitoring: Reanalysis turnaround and analyst correction audit processes need local confirmation.
• 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 PubMed and clinical-trial candidate arrays are empty and were screened. No study was fabricated from vendor validation material. 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, acr ai central product, fda decision summary, vendor product page, literature index, trial registry, recall database, pubmed, clinical trials, openfda device recall

• K260497 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
• DEEPVESSEL Plaque model card (K260497) 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
• DEEPVESSEL Plaque: K260497 decision and 510(k) summary U.S. Food and Drug Administration · 2026-09-05
• DEEPVESSEL Plaque Keya Medical · 2026-09-05