Identity
- Trade Name
- Rayvolve FDA UDI
- Generic Name
- X-ray image interpretive software FDA UDI
- Device Name
- 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) FDA UDI
- Model / Reference
- 4 FDA UDI
- Description
- 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) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770018071060 FDA UDI
- 510(k) Number
- K240845 FDA UDI
- FDA Product Code
- QBS FDA UDI
- GMDN Term
- X-ray image interpretive software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2090 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: X-ray image interpretive software
Rayvolve by Azmed Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Azmed Sas
Sources (1)
- FDA UDI f704095f-44df-4f7c-a7dd-e4adb2294654 34 fields · synced May 30, 2026