Auto Positioning

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 Auto Positioning.

Pre-market Notification Details

Device IDK192956
510k NumberK192956
Device Name:Auto Positioning
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE Hangwei Medical Systems, Co., Ltd. West Area Of Building No.3, No.1 Yongchang North Road Beijing,  CN 100176
ContactYonghui Han
CorrespondentYonghui Han
GE Hangwei Medical Systems, Co., Ltd. West Area Of Building No.3, No.1 Yongchang North Road Beijing,  CN 100176
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-21
Decision Date2020-01-16

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