Transparency Registry · product code QBS
Fracture detection AI: all 10 FDA clearances
Radiological Computer Assisted Detection/Diagnosis Software For Fracture. Computer-assisted detection software for fractures on radiological images. This list is generated from openFDA public records and refreshes automatically every week — bookmark it and it stays current.
| Device | Applicant | Decision date |
|---|---|---|
| Rayvolve | AZmed | 2026-05-12 |
| TechCare Trauma | Milvue | 2025-01-17 |
| icobrain aria | Icometrix NV | 2024-11-07 |
| Rayvolve | Azmed Sas | 2024-07-17 |
| Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | Ge Medical Systems, LLC | 2023-05-25 |
| BoneView | Gleamer | 2023-03-02 |
| Rayvolve | Azmed Sas | 2022-06-02 |
| BoneView | Gleamer | 2022-03-01 |
| FractureDetect (FX) | Imagen Technologies, Inc. | 2020-07-30 |
| OsteoDetect | Imagen Technologies, Inc. | 2018-05-24 |
Facts only, sourced per entry. Listing is not evaluation. Full methodology on the registry index. Evaluating this category? The due-diligence checklist and free instruments are where buyers start.