FDA Product Code
FDA Product Code QBS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2090
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261378 | Rayvolve AZchest | AZmed | 2026-08-28 | Traditional | PDF ↗ |
| K260378 | Rayvolve | AZmed | 2026-05-12 | Traditional | PDF ↗ |
| K242171 | TechCare Trauma | Milvue | 2025-01-17 | Traditional | PDF ↗ |
| K240712 | icobrain aria | Icometrix NV | 2024-11-07 | Traditional | PDF ↗ |
| K240845 | Rayvolve | Azmed Sas | 2024-07-17 | Traditional | PDF ↗ |
| K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | Ge Medical Systems, LLC | 2023-05-25 | Traditional | PDF ↗ |
| K222176 | BoneView | Gleamer | 2023-03-02 | Traditional | PDF ↗ |
| K220164 | Rayvolve | Azmed Sas | 2022-06-02 | Traditional | PDF ↗ |
| K212365 | BoneView | Gleamer | 2022-03-01 | Traditional | PDF ↗ |
| K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | 2020-07-30 | Traditional | PDF ↗ |
| DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018-05-24 | Direct | — |
Product code QBS · Class II · Radiology. Data: openFDA.