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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K163294
Device Name syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
40 LIBERTY BLVD
MAIL CODE 65-1A
MALVERN,  PA  19355
Applicant Contact CORDELL L. FIELDS
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
65 VALLEY STREAM PKWY
MAIL CODE 65-1A
MALVERN,  PA  19355
Correspondent Contact CORDELL L. FIELDS
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
LNH  
Date Received11/22/2016
Decision Date 02/06/2017
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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