GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT

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 Acs-nt, Gyroscan T5-nt And Gyroscan T10-nt.

Pre-market Notification Details

Device IDK945945
510k NumberK945945
Device Name:GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
ContactPeter Altman
CorrespondentPeter Altman
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 Received1994-12-05
Decision Date1995-12-22

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