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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 K221501
Device Name syngo.via View&GO
Applicant
Siemens Healthcare GmbH
Siemensstraße 1, Forchheim
Erlangen,  DE
Applicant Contact Frederike Jakob
Correspondent
Siemens Healthcare GmbH
Siemensstraße 1, Forchheim
Erlangen,  DE
Correspondent Contact Frederike Jakob
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/23/2022
Decision Date 10/14/2022
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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