GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE

System, Nuclear Magnetic Resonance Imaging

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 Gyroscan T5 Magnetic Resonance Diagnostic Device.

Pre-market Notification Details

Device IDK890789
510k NumberK890789
Device Name:GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
ContactRichard M Sano
CorrespondentRichard M Sano
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-15
Decision Date1989-04-28

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