QBS — Radiological Computer Assisted Detection/Diagnosis Software For Fracture Class II
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 |
|---|---|---|---|
| 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 |