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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 K143416
Device Name SOMATOM Definition Flash (VA48)
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN,  PA  19355
Applicant Contact Eve Davis
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
MALVERN,  PA  19355
Correspondent Contact Eve Davis
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/28/2014
Decision Date 04/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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