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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 K232744
Device Name syngo Virtual Cockpit (VB10A)
Applicant
Siemens Healthcare GmbH
Henkestr. 127
Erlangen,  DE 91052
Applicant Contact Jiayan Liu
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
JAK   LNH  
Date Received09/07/2023
Decision Date 12/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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