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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 K050602
Device Name ALTAIRE
Applicant
Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg,  OH  44087
Applicant Contact DOUG THISTLETHWAITE
Correspondent
Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg,  OH  44087
Correspondent Contact DOUG THISTLETHWAITE
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/09/2005
Decision Date 04/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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