EXTRA LARGE QUAD FLEX SPINE COIL

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 Extra Large Quad Flex Spine Coil.

Pre-market Notification Details

Device IDK934719
510k NumberK934719
Device Name:EXTRA LARGE QUAD FLEX SPINE COIL
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg,  OH  44087
ContactJames J Rogers
CorrespondentJames J 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 Received1993-10-01
Decision Date1994-01-05

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