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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K232096
Device Name Transpara Density 1.0.0
Applicant
Screenpoint Medical B.V.
Mercator II, 7th floor, Toernooiveld 300
Nijmegen,  NL 6525EC
Applicant Contact Robin Barwegen
Correspondent
Screenpoint Medical B.V.
Mercator II, 7th floor, Toernooiveld 300
Nijmegen,  NL 6525EC
Correspondent Contact Robin Barwegen
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/13/2023
Decision Date 12/11/2023
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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