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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Medical Image
510(k) Number K213353
Device Name Aorta-CAD
Applicant
Imagen Technologies, Inc
151 West 26th Street, Suite 1001
New York,  NY  10001
Applicant Contact Robert Lindsey
Correspondent
Imagen Technologies, Inc
151 West 26th Street, 10th Floor
New York,  NY  10001
Correspondent Contact Robert Lindsey
Regulation Number892.2070
Classification Product Code
MYN  
Date Received10/08/2021
Decision Date 09/20/2022
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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