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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 K943321
Device Name QUAD PELVIS COIL
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 Received07/11/1994
Decision Date 09/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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