FDA-cleared K260378

Rayvolve

AZmed

Rayvolve supports clinicians by identifying suspected fractures, joint effusions, and dislocations on labeled radiographic views; it does not replace clinician interpretation.

Modality
X-ray/Radiography
Anatomy
Musculoskeletal and chest/ribs radiographs across specified views
Decision
2026-05-12
FDA-cleared K243831

Rayvolve LN

AZmed

Second-reader support for radiologists reviewing adult digital AP or PA chest radiographs, with suspected pulmonary nodules in the 6-30 mm range marked for review.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2025-03-26
FDA-cleared K243808

Rayvolve PTX-PE

AZmed

Passive study-level worklist triage for suspected pneumothorax and/or pleural effusion on adult PA or AP chest X-rays; it is not a proactive specialist alert.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2025-03-21