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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 K914019
Device Name MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)
Applicant
Hitachi Medical Systems America, Inc.
1963 Case Pkwy.
Twinsburg,  OH  44087
Applicant Contact JOCHEN ROGERS
Correspondent
Hitachi Medical Systems America, Inc.
1963 Case Pkwy.
Twinsburg,  OH  44087
Correspondent Contact JOCHEN ROGERS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/09/1991
Decision Date 11/01/1991
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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