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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 K961969
Device Name HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE
Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1963 CASE PKWY.
TWINSBURG,  OH  44087
Applicant Contact JAMES J ROGERS
Correspondent
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1963 CASE PKWY.
TWINSBURG,  OH  44087
Correspondent Contact JAMES J ROGERS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/20/1996
Decision Date 09/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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