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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
Predetermined Change
Control Plan Authorized		 No
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