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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 K945155
Device Name AIRIS
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 Received10/21/1994
Decision Date 05/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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