AZMed Rayvolve
Rayvolve is a computer‑assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adults only (22 years old). Rayvolve is indicated for radiographs of the following industry‑standard radiographic views and study types.
Study Type (Anatomic Area of interest)/ Radiographic Views supported:
- Ankle/Frontal, Lateral,Oblique
- Clavicle/Frontal
- Elbow/Frontal, Lateral
- Forearm/Frontal, Lateral
- Hip/Frontal, Frog Leg Lateral
- Humerus/Frontal, Lateral
- Knee/Frontal, Lateral
- Pelvis/Frontal
- Shoulder/Frontal, Lateral, Axillary
- Tibia/fibula/Frontal, Lateral
- Wrist/Frontal, Lateral, Oblique
- Hand/Frontal, Lateral
- Foot/Frontal, Lateral
*For the purposes of this table, "Frontal" is considered inclusive of both posteroanterior (PA) and anteroposterior (AP) views.
+Definitions of anatomic area of interest and radiographic views are consistent with the American College of Radiology (ACR) standards and guidelines.
FDA 510(k): K220164
HC_4404_December2024
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