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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K140232
Device Name SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Malvern,  PA  19355 -1406
Applicant Contact EVE DAVIS
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Malvern,  PA  19355 -1406
Correspondent Contact EVE DAVIS
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/30/2014
Decision Date 08/14/2014
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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