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U.S. Department of Health and Human Services

510(k) Premarket Notification

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41 to 50 of 54 Results
ProductCode: LNH Applicant: HITACHI MEDICAL SYSTEMS AMERICA, INC Decision Date To: 09/25/2016
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mrp-5000 & mrp-7000 hs/mr quadrature knee coils HITACHI MEDICAL SYSTEMS AMERICA, INC. K914263 11/22/1991
mrp-5000 and 7000 bilateral/unilateral tmj coil HITACHI MEDICAL SYSTEMS AMERICA, INC. K923140 12/24/1992
mrp-5000 and mrp-7000 multiplanar reconstruction HITACHI MEDICAL SYSTEMS AMERICA, INC. K911642 05/30/1991
mrp-5000 hs/mr quadrature body coil(p/n mr-qbc-31) HITACHI MEDICAL SYSTEMS AMERICA, INC. K914019 11/01/1991
qd bilateral breast coil HITACHI MEDICAL SYSTEMS AMERICA, INC. K953262 10/17/1995
quad pelvis coil HITACHI MEDICAL SYSTEMS AMERICA, INC. K943321 09/23/1994
stratis HITACHI MEDICAL SYSTEMS AMERICA, INC. K945386 03/21/1995
stratis ii HITACHI MEDICAL SYSTEMS AMERICA, INC. K974498 02/26/1998
trillium oval mr system HITACHI MEDICAL SYSTEMS AMERICA, INC. K142734 03/02/2015
trillium oval v 5.1 mri system HITACHI MEDICAL SYSTEMS AMERICA, INC. K160152 05/20/2016
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