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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 K932244
Device Name SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM
Applicant
Shimadzu Medical Systems
101 W. Walnut St.
Gardena,  CA  90248
Applicant Contact KIYOSHI KUME
Correspondent
Shimadzu Medical Systems
101 W. Walnut St.
Gardena,  CA  90248
Correspondent Contact KIYOSHI KUME
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/10/1993
Decision Date 02/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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