AZmed SAS radiology AI products

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Which exact product, version and licensed modules are in the current offer?
Do related FDA submissions document the same scope, or different functions and versions?
Which costs, support obligations and local acceptance tests remain unresolved?

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Radiology AI pricing and total cost of ownership

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FDA-cleared K240845

Rayvolve

AZmed SAS

Authorized purpose: 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 anatomic areas and standard views (ankle, clavicle, elbow, forearm, hip, humerus, knee, pelvis, shoulder, tibia/fibula, wrist, hand, and foot); it is an aided-diagnosis device and does not operate autonomously.

Modality: X-ray/Radiography
Anatomy: MSK
Decision: 2024-07-17

MSK and bone Detection and CADe

FDA-cleared K220164

Rayvolve

AZmed SAS

Authorized purpose: Computer-assisted detection and diagnosis to assist radiologists and emergency physicians in detecting fractures on specified adult musculoskeletal radiographs; indicated for adults at least 22 years old.

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 bone Detection and CADe