ADVANTAGE SIM

System, Simulation, Radiation Therapy

GENERAL ELECTRIC CO.

The following data is part of a premarket notification filed by General Electric Co. with the FDA for Advantage Sim.

Pre-market Notification Details

Device IDK951830
510k NumberK951830
Device Name:ADVANTAGE SIM
ClassificationSystem, Simulation, Radiation Therapy
Applicant GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee,  WI  53201
ContactLarry A Kroger
CorrespondentLarry A Kroger
GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee,  WI  53201
Product CodeKPQ  
CFR Regulation Number892.5840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-20
Decision Date1995-11-13

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