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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 K223811
Device Name Lung-CAD
Applicant
Imagen Technologies, Inc.
594 Broadway Suite 701
New York,  NY  10012
Applicant Contact Rebecca Jones, PhD
Correspondent
Imagen Technologies, Inc.
594 Broadway Suite 701
New York,  NY  10012
Correspondent Contact Rebecca Jones, PhD
Regulation Number892.2070
Classification Product Code
MYN  
Date Received12/20/2022
Decision Date 09/13/2023
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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