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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 K984280
Device Name AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
Applicant
Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg,  OH  44087
Applicant Contact JAMES JOCHEN ROGERS
Correspondent
Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg,  OH  44087
Correspondent Contact JAMES JOCHEN ROGERS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/30/1998
Decision Date 02/08/1999
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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