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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 K210404
Device Name Transpara 1.7.0
Applicant
ScreenPoint Medical B.V.
Mercator II, 7th floor, Toernooiveld 300
Nijmegen,  NL 6525EC
Applicant Contact Umar Waqas
Correspondent
ScreenPoint Medical B.V.
Mercator II, 7th floor, Toernooiveld 300
Nijmegen,  NL 6525EC
Correspondent Contact Umar Waqas
Classification Product Code
QDQ  
Date Received02/10/2021
Decision Date 06/02/2021
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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