AIRIS ELITE RAPID BODY COIL

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 Elite Rapid Body Coil.

Pre-market Notification Details

Device IDK050307
510k NumberK050307
Device Name:AIRIS ELITE RAPID BODY COIL
ClassificationCoil, Magnetic Resonance, Specialty
Applicant HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg,  OH  44087
ContactDouglas Thistlethwaite
CorrespondentDouglas Thistlethwaite
HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg,  OH  44087
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-08
Decision Date2005-02-28
Summary:summary

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