2D, 3D TOF MR ANGIOGRAPHY

System, Nuclear Magnetic Resonance Imaging

HITACHI MEDICAL SYSTEMS AMERICA, INC.

The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for 2d, 3d Tof Mr Angiography.

Pre-market Notification Details

Device IDK935671
510k NumberK935671
Device Name:2D, 3D TOF MR ANGIOGRAPHY
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg,  OH  44087
ContactJames Jochen Rogers
CorrespondentJames Jochen Rogers
HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg,  OH  44087
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-26
Decision Date1994-03-30

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