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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 K203258
Device Name syngo.CT Lung CAD
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 Received11/05/2020
Decision Date 03/31/2021
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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