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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 K240294
Device Name Syngo Carbon Enterprise Access (VA40A)
Applicant
Siemens Healthcare GmbH
Siemensstraße 3
Forchheim,  DE 91301
Applicant Contact Vijay Ramadas
Correspondent
Siemens Healthcare GmbH
Siemensstraße 3
Forchheim,  DE 91301
Correspondent Contact Vijay Ramadas
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/01/2024
Decision Date 05/23/2024
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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