TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T

Coil, Magnetic Resonance, Specialty

PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Tansmit/receive Quadrature Body Coil 3.0t.

Pre-market Notification Details

Device IDK013894
510k NumberK013894
Device Name:TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
ClassificationCoil, Magnetic Resonance, Specialty
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 22100 BOTHELL EVERETT HWY P.O. BOX 3003 Bothell,  WA  98041 -3003
ContactLynn Harmer
CorrespondentLynn Harmer
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 22100 BOTHELL EVERETT HWY P.O. BOX 3003 Bothell,  WA  98041 -3003
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-11-23
Decision Date2002-01-18
Summary:summary

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