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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 K213544
Device Name TOMTEC-ARENA
Applicant
TOMTEC Imaging Systems GmbH
Freisinger Strasse 9
Unterschleissheim,  DE 85716
Applicant Contact Marc Bergenthal
Correspondent
TOMTEC Imaging Systems GmbH
Freisinger Strasse 9
Unterschleissheim,  DE 85716
Correspondent Contact Marc Bergenthal
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received11/08/2021
Decision Date 01/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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