Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT With Apex Edition; Revolution CT ES 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 Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,revolution Ct; Revolution Ct Es; Revolution Ct With Apex Edition; Revolution Ct Es With Apex Edition.

Pre-market Notification Details

Device IDK213715
510k NumberK213715
Device Name:Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT With Apex Edition; Revolution CT ES With Apex Edition
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE Medical Systems,LLC 3000 N Grandview Blvd. Waukesha,  WI  53188
ContactKatelyn Rowley
CorrespondentKatelyn Rowley
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 Received2021-11-24
Decision Date2021-12-17

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