QBS
10 FDA 510(k) clearances · Product code
185 daysmedian time to decision
237 days90th percentile
10clearances measured
FDA profile
- Official device name
- Radiological Computer Assisted Detection/Diagnosis Software For Fracture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2090
- Medical specialty
- Radiology
- FDA definition
- A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide information about the presence, location, and/or characteristics of the fracture to the user. Primary diagnostic and patient management decisions are made by the clinical user.
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| Record | Firm | Date |
|---|---|---|
| Rayvolve (K260378) | AZmed | 2026-05-12 |
| TechCare Trauma (K242171) | Milvue | 2025-01-17 |
| icobrain aria (K240712) | Icometrix NV | 2024-11-07 |
| Rayvolve (K240845) | Azmed Sas | 2024-07-17 |
| Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite (K223491) | Ge Medical Systems, LLC | 2023-05-25 |
| BoneView (K222176) | Gleamer | 2023-03-02 |
| Rayvolve (K220164) | Azmed Sas | 2022-06-02 |
| BoneView (K212365) | Gleamer | 2022-03-01 |
| FractureDetect (FX) (K193417) | Imagen Technologies, Inc. | 2020-07-30 |
| OsteoDetect (DEN180005) | Imagen Technologies, Inc. | 2018-05-24 |
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Every clearance here is in the API, with alerts when new ones post.