QBS — Radiological Computer Assisted Detection/Diagnosis Software For Fracture Class II
FDA product code QBS covers "Radiological Computer Assisted Detection/Diagnosis Software For Fracture", a Class II medical device regulated under 21 CFR 892.2090. Submissions are reviewed by the Radiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QBS
- Device Class
- Class II
- Regulation Number
- 892.2090
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260378 | azmed | Rayvolve | May 12, 2026 |
| K242171 | milvue | TechCare Trauma | January 17, 2025 |
| K240712 | icometrix | icobrain aria | November 7, 2024 |
| K240845 | azmed | Rayvolve | July 17, 2024 |
| K223491 | ge medical systems | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suit | May 25, 2023 |
| K222176 | gleamer | BoneView | March 2, 2023 |
| K220164 | azmed | Rayvolve | June 2, 2022 |
| K212365 | gleamer | BoneView | March 1, 2022 |
| K193417 | imagen technologies | FractureDetect (FX) | July 30, 2020 |
| DEN180005 | imagen technologies | OsteoDetect | May 24, 2018 |