Revolution CT

System, X-ray, Tomography, Computed

GE Medical Systems, L.L.C.

The following data is part of a premarket notification filed by Ge Medical Systems, L.l.c. with the FDA for Revolution Ct.

Pre-market Notification Details

Device IDK163213
510k NumberK163213
Device Name:Revolution CT
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE Medical Systems, L.L.C. 3000 N Grandview Blvd Waukesha,  WI  53188
ContactHelen Peng
CorrespondentHelen Peng
GE Medical Systems, L.L.C. 3000 N Grandview Blvd Waukesha,  WI  53188
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-16
Decision Date2016-12-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682143646 K163213 000
00840682138796 K163213 000
00840682123471 K163213 000

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