QBS

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Product code

QBS

Device name

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Device class

Class 2

21 CFR

21 CFR 892.2090

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

11

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-08-28.