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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 K122471
Device Name SOMATOM DEFINITION
Applicant
Siemens Medical Systems, Inc.
51 Valley Stream Pkwy.
Malvern,  PA  19355 -1406
Applicant Contact KIMBERLY MANGUN
Correspondent
Siemens Medical Systems, Inc.
51 Valley Stream Pkwy.
Malvern,  PA  19355 -1406
Correspondent Contact KIMBERLY MANGUN
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/14/2012
Decision Date 09/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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