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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 K974212
Device Name AIRIS II
Applicant
Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg,  OH  44087
Applicant Contact JAMES J ROGERS
Correspondent
Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg,  OH  44087
Correspondent Contact JAMES J ROGERS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/10/1997
Decision Date 02/09/1998
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
Recalls CDRH Recalls
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