GE ROAD WARRIOR PET CT IMAGING SYSTEM

System, Tomography, Computed, Emission

GENERAL ELECTRIC CO.

The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Road Warrior Pet Ct Imaging System.

Pre-market Notification Details

Device IDK022872
510k NumberK022872
Device Name:GE ROAD WARRIOR PET CT IMAGING SYSTEM
ClassificationSystem, Tomography, Computed, Emission
Applicant GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee,  WI  53201
ContactDavid Duersteler
CorrespondentDavid Duersteler
GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee,  WI  53201
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-29
Decision Date2002-09-12
Summary:summary

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