Rayvolve PTX-PE

Evidence summary

The FDA-described validation included 1,000 pneumothorax and 1,000 pleural-effusion radiographs. Pneumothorax sensitivity was 0.9379, specificity 0.9178 and AUC 0.9857. Pleural-effusion sensitivity was 0.9134, specificity 0.9448 and AUC 0.9830. Reported processing times were about 19.43 and 19.56 seconds respectively.

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 PTX-PE 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

• FDA 510(k) K243808: Rayvolve PTX-PE U.S. Food and Drug Administration · 2026-09-07
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• Rayvolve PTX-PE model card (K243808) 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
• AI Radiology: Fracture Detection, Chest, Measure, BoneAge AZmed · 2026-09-06