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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 Lesions Suspicious For Cancer
510(k) Number K221347
Device Name Transpara 1.7.2
Applicant
Screenpoint Medical B.V.
Mercator Ii, 7th Floor, Teornooiveld 300
Nijmegen,  NL 6525EC
Applicant Contact Robin Barwegen
Correspondent
Screenpoint Medical B.V.
Mercator Ii, 7th Floor, Teornooiveld 300
Nijmegen,  NL 6525EC
Correspondent Contact Robin Barwegen
Classification Product Code
QDQ  
Date Received05/09/2022
Decision Date 08/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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