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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 K110366
Device Name SYNGO.CT CARDIAC FUNCTION
Applicant
Siemens AG
51 Valley Stream Pkwy.
Mavern,  PA  19355
Applicant Contact RALF HOFFMANN
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact NORBERT STUIBER
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/07/2011
Decision Date 04/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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