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Radiological Computer Assisted Detection/Diagnosis Software For Fracture

FDA product code QBS · 10 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.2090
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-07-30 – 2026-08-28

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.

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