AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Coil, Magnetic Resonance, Specialty

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 Airis Magnetic Resonance Diagnostic Device.

Pre-market Notification Details

Device IDK980691
510k NumberK980691
Device Name:AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
ClassificationCoil, Magnetic Resonance, Specialty
Applicant HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg,  OH  44087
ContactJames Jochen Rogers
CorrespondentJames Jochen Rogers
HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg,  OH  44087
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-23
Decision Date1998-05-11
Summary:summary

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