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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 K150122
Device Name TOMTEC-ARENA TTA2
Applicant
TOMTEC IMAGING SYSTEMS, GMBH
EDISONSTRASSE 6
UNTERSCHLEISSHEIM,  DE D-85716
Applicant Contact CHRISTINE KLEIN
Correspondent
TOMTEC IMAGING SYSTEMS, GMBH
EDISONSTRASSE 6
UNTERSCHLEISSHEIM,  DE D-85716
Correspondent Contact CHRISTINE KLEIN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/20/2015
Decision Date 02/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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