Radiology AI Directory

Vendor

AZmed SAS

2 FDA-cleared listings in this directory.

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FDA-cleared K240845

Rayvolve

AZmed SAS

Assists radiologists and emergency physicians in detecting fractures on DICOM musculoskeletal radiographs for adults and children aged 2 years or older, limited to the FDA-listed...

Modality
X-ray/Radiography
Anatomy
MSK
Decision
2024-07-17
MSK and boneDetection and CADe
FDA-cleared K220164

Rayvolve

AZmed SAS

Computer-assisted detection and diagnosis to assist radiologists and emergency physicians in detecting fractures on specified adult musculoskeletal radiographs; indicated for...

Modality
X-ray/Radiography
Anatomy
Musculoskeletal system: ankle, clavicle, elbow, forearm, hip, humerus, knee, pelvis, shoulder, tibia/fibula, wrist, hand, and foot
Decision
2022-06-02
MSK and boneDetection and CADe