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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 K123541
Device Name SYNGO.CT NEURO PERFUSION
Applicant
SIEMENS MEDICAL SYSTEMS, INC.
51 VALLEY STREAM PARKWAY
MALVERN,  PA  19355
Applicant Contact KIMBERLY MANGUM
Correspondent
SIEMENS MEDICAL SYSTEMS, INC.
51 VALLEY STREAM PARKWAY
MALVERN,  PA  19355
Correspondent Contact KIMBERLY MANGUM
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/19/2012
Decision Date 04/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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