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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K925107
Device Name SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM
Applicant
SHIMADZU MEDICAL SYSTEMS
101 WEST WALNUT ST.
GARDENIA,  CA  90248
Applicant Contact DE MINT
Correspondent
SHIMADZU MEDICAL SYSTEMS
101 WEST WALNUT ST.
GARDENIA,  CA  90248
Correspondent Contact DE MINT
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/09/1992
Decision Date 01/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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