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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 K182208
Device Name syngo.via View&GO (Version VA10A)
Applicant
Siemens Healthcare GmbH
Siemensstr. 1
Forchheim,  DE 91301
Applicant Contact Elango Alampalayam Rangappan
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact Alexander Schapovalov
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/15/2018
Decision Date 09/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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