Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Regulation 892.2090
3510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QBS
| Company | 510(k)s | Recalls |
|---|---|---|
| AZmed | 4 | 0 |
| Gleamer | 2 | 0 |
| Imagen Technologies, Inc. | 2 | 0 |
| Avicenna.Ai | 1 | 0 |
| Ge Medical Systems, LLC | 1 | 0 |
| Icometrix NV | 1 | 0 |
| Milvue | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 2026 | K262062 | CINA-Aneurysm Avicenna.Ai, FR | QBS |
| Aug 28, 2026 | K261378 | Rayvolve AZchest AZmed, FR | QBS |
| May 12, 2026 | K260378 | Rayvolve AZmed, FR | QBS |
| Jan 17, 2025 | K242171 | TechCare Trauma Milvue, FR | QBS |
| Nov 7, 2024 | K240712 | icobrain aria Icometrix NV, BE | QBS |
| Jul 17, 2024 | K240845 | Rayvolve Azmed Sas, FR | QBS |
| May 25, 2023 | K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite Ge Medical Systems, LLC | QBS |
| Mar 2, 2023 | K222176 | BoneView Gleamer, FR | QBS |
| Jun 2, 2022 | K220164 | Rayvolve Azmed Sas, FR | QBS |
| Mar 1, 2022 | K212365 | BoneView Gleamer, FR | QBS |
| Jul 30, 2020 | K193417 | FractureDetect (FX) Imagen Technologies, Inc. | QBS |
| May 24, 2018 | DEN180005 | OsteoDetect Imagen Technologies, Inc. | QBS |
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