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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 K210666
Device Name Chest-CAD
Applicant
Imagen Technologies, Inc.
151 W. 26th St.
Suite 1001
New York,  NY  10001
Applicant Contact Robert Lindsey
Correspondent
Imagen Technologies, Inc.
151 W. 26th St., 10th Floor
New York,  NY  10001
Correspondent Contact Robert Lindsey
Regulation Number892.2070
Classification Product Code
MYN  
Date Received03/05/2021
Decision Date 07/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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