Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT With Apex Edition

System, X-ray, Tomography, Computed

GE Medical Systems, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Revolution Ct, Revolution Ct Es, Revolution Apex, Revolution Ct With Apex Edition.

Pre-market Notification Details

Device IDK191777
510k NumberK191777
Device Name:Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT With Apex Edition
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE Medical Systems, LLC 3000 N. Grandview Blvd Waukesha,  WI  53188
ContactLaura Turner
CorrespondentLaura Turner
GE Medical Systems, LLC 3000 N. Grandview Blvd Waukesha,  WI  53188
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-02
Decision Date2019-07-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682146616 K191777 000
00840682146319 K191777 000

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