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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)
Siemens Healthcare GmbH
Siemensstr. 1
Forchheim,  DE 91301
Applicant Contact Abhineet Johri
Siemens Healthcare GmbH
Siemensstr. 1
Forchheim,  DE 91301
Correspondent Contact Abhineet Johri
Regulation Number892.2050
Classification Product Code
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