Rayvolve PTX-PE
AZmed
AZmed
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3026753394 | 3026753394 | AZMED SAS | 1 | N | 2026-01-01 | 10 Rue D'Uzes Paris FR 75002 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 313513 | 1940016810 | K243831 | Rayvolve LN | MYN | 2025-03-26 |
| 313513 | 1291779225 | K243808 | Rayvolve PTX-PE | QFM | 2025-03-21 |
| 313513 | 1596545555 | K240845 | Rayvolve | QBS | 2024-07-17 |
| 313513 | 1516082798 | K220164 | Rayvolve | QBS | 2022-06-02 |
Product Codes Associated With Registrations
PMN
GUDID
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 adult and pediatric population (2 years and over). (Variant : VM + Cloud)
2024-10-11
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 adult and pediatric population (2 years and over). (Variant : Full Cloud)
2024-10-11
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 adult and pediatric population (2 years and over).
2024-10-11
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 adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : On premise)
2024-06-10
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 adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : Full Cloud)
2024-03-18
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 adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : Cloud/VM)
2024-03-18