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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lung Computed Tomography System, Computer-Aided Detection
510(k) Number K231157
Device Name syngo.CT Lung CAD (Version VD30)
Applicant
Siemens Healthcare GmbH
Siemensstr. 1
Forchheim,  DE 91301
Applicant Contact Abhineet Johri
Correspondent
Siemens Healthcare GmbH
Siemensstr. 1
Forchheim,  DE 91301
Correspondent Contact Abhineet Johri
Regulation Number892.2050
Classification Product Code
OEB  
Date Received04/24/2023
Decision Date 07/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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