510(k) K242171
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2025
- Date Received
- July 24, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiological Computer Assisted Detection/Diagnosis Software For Fracture
- Device Class
- Class II
- Regulation Number
- 892.2090
- Review Panel
- RA
- Submission Type
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.