OPTIMA CT520

System, X-ray, Tomography, Computed

GE HANGWEI MEDICAL SYSTEMS CO., LTD.

The following data is part of a premarket notification filed by Ge Hangwei Medical Systems Co., Ltd. with the FDA for Optima Ct520.

Pre-market Notification Details

Device IDK123596
510k NumberK123596
Device Name:OPTIMA CT520
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE HANGWEI MEDICAL SYSTEMS CO., LTD. NO. 2 N. YONGCHANG STREET BEIJING ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA Beijing,  CN 100176
ContactHelen Peng
CorrespondentHelen Peng
GE HANGWEI MEDICAL SYSTEMS CO., LTD. NO. 2 N. YONGCHANG STREET BEIJING ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA Beijing,  CN 100176
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-21
Decision Date2013-02-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682147415 K123596 000
00840682102568 K123596 000
00195278403087 K123596 000
00195278385215 K123596 000

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