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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Software device that receives radiological images as an input and provides a concurrent read for presence or absence of fracture (detection and diagnosis) as an output
Technical Method Analyzes radiological images using machine learning algorithms to detect and diagnose fracture.
Target Area Radiological images of anatomical sites that main contain fracture.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeQBS
Premarket Review Division of Radiological Health (DRH)
Division of Radiological Health (DRH)
Submission Type 510(k)
Regulation Number 892.2090
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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