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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 K122909
Device Name SYNGO SINGLE SOURCE DUAL ENGERY
Applicant
SIEMENS MEDICAL SYSTEMS, INC.
51 valley stream parkway
malvern,  PA  19355 1406
Contact kimberly mangum
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/21/2012
Decision Date 12/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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