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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 K920159
Device Name MOBILE MRP-7000
Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
77 MILFORD RD.
HUDSON,  OH  44236
Applicant Contact JOCHEN ROGERS
Correspondent
HITACHI MEDICAL SYSTEMS AMERICA, INC.
77 MILFORD RD.
HUDSON,  OH  44236
Correspondent Contact JOCHEN ROGERS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/14/1992
Decision Date 03/05/1992
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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