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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 K002420
Device Name HITACHI ALTAIRE
Original Applicant
HITACHI MEDICAL SYSTEMS AMERICA, INC.
1959 summit commerce park
twinsburg,  OH  44087
Original Contact douglas thistlethwaite
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/08/2000
Decision Date 10/17/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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