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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K201632
Device Name TOMTEC-ARENA
Applicant
TOMTEC Imaging Systems GmbH
Edisonstrasse 6
Unterschleissheim,  DE 85716
Applicant Contact Marc Bergenthal
Correspondent
TOMTEC Imaging Systems GmbH
Edisonstrasse 6
Unterschleissheim,  DE 85716
Correspondent Contact Marc Bergenthal
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
QIH  
Date Received06/16/2020
Decision Date 08/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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