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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 K130998
Device Name SYNGO.VIA WEB VIEWER
Applicant
SIEMENS AG, MEDICAL SOLUTIONS
HENKESTRASSE 127
erlangen,  DE 91052
Applicant Contact sabine schroedel
Correspondent
SIEMENS AG, MEDICAL SOLUTIONS
HENKESTRASSE 127
erlangen,  DE 91052
Correspondent Contact sabine schroedel
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/10/2013
Decision Date 01/03/2014
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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