Rayvolve

Evidence summary

The FDA packet describes standalone and reader assessments; numeric results are not repeated here because the table endpoint/version details need a further exact extraction before comparison.

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 security and privacy controls: No dated, scoped security attestation was reviewed.
• Verify training: The FDA packet says user instructions are transmitted to each user; current onboarding/support terms were not established.
• Verify pricing and total cost: No scoped public price or procurement award was reviewed.
• 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.

All stored metadata records were screened. PMID 34810137 is retained as contextual family evidence; remaining literature leads and NCT05187585 lacked exact K260378 configuration linkage or complete readable protocol/results, so no additional results were promoted. The current discovery snapshot contains 9 PubMed and 1 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 material, vendor product page, literature index, trial registry, fda device recall, pubmed, clinical trials, openfda device recall

• FDA 510(k) K260378: Rayvolve U.S. Food and Drug Administration · 2026-09-05
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• Rayvolve model card (K260378) 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
• AZmed's AI Tool Rayvolve Gains FDA Clearance for Fracture Detection AZmed · 2026-09-05
• Artificial intelligence algorithm for fracture detection in pediatric radiographs Diagnostic and Interventional Imaging; abstract via PubMed · 2026-09-05