Rayvolve LN

Evidence summary

In the FDA-described standalone test of 2,181 radiographs, sensitivity was 0.8847, specificity was 0.8294 and AUC was 0.8408. In a separate 400-case MRMC study, the FDA table reports AUC improvement from 0.8071 unaided to 0.8583 aided, sensitivity from 0.7975 unaided to 0.8935 aided, and specificity from 0.8235 unaided to 0.8510 aided. These are exact-submission study results and not current family claims.

• FDA source
• Exact FDA submission
• Checked 2026-09-07

• Source

Postmarket safety review

Not established in reviewed sources

• Reviewed sources checked
• Exact FDA submission
• Checked 2026-09-07

The downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

• Verify security and privacy controls: The reviewed sources do not establish exact-release security controls, retention or assurance documentation.
• Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
• Verify pricing and total cost: No public price or quote for Rayvolve LN was reviewed.
• Verify reimbursement and coding relevance: Payer policy research was not part of this worker's scope.
• 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: The downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

Stored candidate metadata was screened; no PubMed or trial IDs were returned for this submission. This is not a full-paper review. 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, fda decision summary, acr ai central product, vendor product page, stored candidate metadata, literature index, trial registry, pubmed, clinical trials, openfda device recall