10 devices · 7 companies · 2018 to 2026
Product code QBS: Radiological Computer Assisted Detection/Diagnosis Software For Fracture
10 devices under product code QBS, 2018 to 2026, from 7 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (10 of 10 here), the regulation, and MAUDE report counts by product code.
Radiological Computer Assisted Detection/Diagnosis Software For Fracture. 21 CFR 892.2090, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| RayvolveK260378 · 510(k) | AZmed | Radiology | database entry | |
| TechCare TraumaK242171 · 510(k) | Milvue | Radiology | database entry | |
| icobrain ariaK240712 · 510(k) | icometrix NV | Radiology | database entry | |
| RayvolveK240845 · 510(k) | AZmed SAS | Radiology | database entry | |
| Critical Care Suite with Pneumothorax DetectionK223491 · 510(k) | GE Medical Systems, LLC | Radiology | database entry | |
| BoneViewK222176 · 510(k) | Gleamer | Radiology | database entry | |
| RayvolveK220164 · 510(k) | AZmed SAS | Radiology | database entry | |
| BoneViewK212365 · 510(k) | Gleamer | Radiology | database entry | |
| FractureDetectK193417 · 510(k) | Imagen Technologies, Inc. | Radiology | database entry | |
| OsteoDetectDEN180005 · De Novo | Imagen Technologies, Inc. | Radiology | database entry |
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