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510(k) K193417

FractureDetect (FX) by Imagen Technologies, Inc. — Product Code QBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2020
Date Received
December 9, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Device Class
Class II
Regulation Number
892.2090
Review Panel
RA
Submission Type

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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