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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K232856
Device Name Syngo Carbon Clinicals
Applicant
Siemens Healthcare GmbH
Siemensstraße 3
Forchheim,  DE 91301
Applicant Contact Ramadas Ramadas
Correspondent
Siemens Healthcare GmbH
Siemensstr. 1,
Forchheim,  DE 91301
Correspondent Contact Vijay Ramadas
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Codes
LLZ   MUJ   OEB  
Date Received09/15/2023
Decision Date 12/01/2023
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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