ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE 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 Echelon Rapid Pv Coil, Model Mr-pvc-150, Echelon Rapid Foot Coil, Model Mr-rfc-150 And Echelon Rapid Knee Coil.

Pre-market Notification Details

Device IDK081745
510k NumberK081745
Device Name:ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL
ClassificationCoil, Magnetic Resonance, Specialty
Applicant HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg,  OH  44087
ContactDoug Thistlewaite
CorrespondentDoug Thistlewaite
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 Received2008-06-19
Decision Date2008-08-12
Summary:summary

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