MOBILE MRP-7000

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 Mobile Mrp-7000.

Pre-market Notification Details

Device IDK920159
510k NumberK920159
Device Name:MOBILE MRP-7000
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant HITACHI MEDICAL SYSTEMS AMERICA, INC. 77 MILFORD RD. Hudson,  OH  44236
ContactJochen Rogers
CorrespondentJochen Rogers
HITACHI MEDICAL SYSTEMS AMERICA, INC. 77 MILFORD RD. Hudson,  OH  44236
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-14
Decision Date1992-03-05

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