LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM

System, X-ray, Tomography, Computed

GE MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Lightspeed 5.0 Computed Tomography System.

Pre-market Notification Details

Device IDK030420
510k NumberK030420
Device Name:LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE MEDICAL SYSTEMS 3000 NORTH GRANDVIEW BLVD. Waukesha,  WI  53188
ContactJohn W Jaeckle
CorrespondentJohn W Jaeckle
GE MEDICAL SYSTEMS 3000 NORTH GRANDVIEW BLVD. Waukesha,  WI  53188
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-10
Decision Date2003-03-10
Summary:summary

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