510(k) K260378
- Device
- Rayvolve
- Applicant
- AZmed
- 510(k) number
- K260378
- Product code
- QBS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-12
- Date received
- 2026-02-05
- Regulation
- 892.2090
- Classification name
- Radiological Computer Assisted Detection/Diagnosis Software For Fracture
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Shanni Zeitoun
- Address
- 10 Rue D'Uzès Paris FR
FDA Registration Numbers#
- 3013427569
- 2126677
- 3014661828
- 9616047
- 3007734888
- 3026753394
- 3021907554
- 3027453703
Source Documents#
Other 510(k) Records For Product Code QBS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242171 | TechCare Trauma | Milvue | 2025-01-17 |
| K240712 | icobrain aria | Icometrix NV | 2024-11-07 |
| K240845 | Rayvolve | Azmed Sas | 2024-07-17 |
| K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | Ge Medical Systems, LLC | 2023-05-25 |
| K222176 | BoneView | Gleamer | 2023-03-02 |
| K220164 | Rayvolve | Azmed Sas | 2022-06-02 |
| K212365 | BoneView | Gleamer | 2022-03-01 |
| K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | 2020-07-30 |
| DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018-05-24 |