510(k) K260378
K260378 is an FDA 510(k) premarket notification submitted by AZmed for the device "Rayvolve". The FDA issued a decision of Substantially Equivalent on May 12, 2026. The device falls under product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture), a Class II device regulated under 21 CFR 892.2090. AZmed has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 2026
- Date Received
- February 5, 2026
- 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.