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510(k) K260378

Rayvolve by AZmed — Product Code QBS

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.

Other clearances by AZmed

  • K243831 — Rayvolve LN (March 26, 2025)
  • K243808 — Rayvolve PTX-PE (March 21, 2025)
  • K240845 — Rayvolve (July 17, 2024)
  • K220164 — Rayvolve (June 2, 2022)

Other clearances for product code QBS

  • K242171 — TechCare Trauma (January 17, 2025)
  • K240712 — icobrain aria (November 7, 2024)
  • K240845 — Rayvolve (July 17, 2024)
  • K223491 — Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suit (May 25, 2023)
  • K222176 — BoneView (March 2, 2023)
  • K220164 — Rayvolve (June 2, 2022)
  • K212365 — BoneView (March 1, 2022)
  • K193417 — FractureDetect (FX) (July 30, 2020)
  • DEN180005 — OsteoDetect (May 24, 2018)