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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 K143196
Device Name syngo.CT Lung CAD
Applicant
Siemens AG Medical Solutions
20 Valley Stream Pkwy.
Malvern,  PA  19355
Applicant Contact JAMES E KUHN JR.
Correspondent
Siemens AG Medical Solutions
20 Valley Stream Pkwy.
Malvern,  PA  19355
Correspondent Contact JAMES E KUHN JR.
Regulation Number892.2050
Classification Product Code
OEB  
Date Received11/06/2014
Decision Date 05/12/2015
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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