TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE

System, X-ray, Tomography, Computed

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 Tomoscan Stereotaxis Simulation Software.

Pre-market Notification Details

Device IDK900660
510k NumberK900660
Device Name:TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE
ClassificationSystem, X-ray, Tomography, Computed
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
ContactWilliam G Mcmahon
CorrespondentWilliam G Mcmahon
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-09
Decision Date1990-03-13

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