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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 K133424
Device Name SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN,  PA  19355 -1406
Applicant Contact KIMBERLY MANGUM
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN,  PA  19355 -1406
Correspondent Contact KIMBERLY MANGUM
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/08/2013
Decision Date 01/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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