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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radiological computer assisted detection/diagnosis software for fracture
510(k) Number K193417
Device Name FractureDetect (FX)
Applicant
Imagen Technologies, Inc.
WeWork, 524 Broadway, 8th Floor
New York,  NY  10012
Applicant Contact Robert Lindsey
Correspondent
Biologics Consulting
1555 King St, Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number892.2090
Classification Product Code
QBS  
Date Received12/09/2019
Decision Date 07/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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