MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT 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 Modification To: Lightspeed Plus Mobile Ct System.

Pre-market Notification Details

Device IDK012836
510k NumberK012836
Device Name:MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee,  WI  53188
ContactLarry A Kroger
CorrespondentLarry A Kroger
GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee,  WI  53188
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-23
Decision Date2001-09-07
Summary:summary

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