DeviceClearance

Product code QBS— Radiology

Rayvolve

Classification name
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Device class
Class 2
Regulation
21 CFR 892.2090
Advisory panel
Radiology
Total cleared
11
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QBS under 21 CFR 892.2090, via openFDA

Market context for product code QBS

FDA has cleared 11 devices under product code QBS between 2018 and 2026, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QBS

Recent clearances under product code QBS

Data sourced from openFDA. This site is unofficial and independent of the FDA.