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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 K121072
Device Name SOMATOM DEFINITION FLASH
Original Applicant
SIEMENS MEDICAL SYSTEMS, INC.
51 valley stream parkway
malvern,  PA  19355 1406
Original Contact kimberly mangum
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/09/2012
Decision Date 05/08/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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