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Device radiological computer assisted detection/diagnosis software for fracture
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.
Product CodeQBS
Regulation Number 892.2090
Device Class 2


Premarket Reviews
ManufacturerDecision
AZMED SAS
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GLEAMER
  SUBSTANTIALLY EQUIVALENT 2
IMAGEN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

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