Image Guidance System For Radiotherapy

Accelerator, Linear, Medical

Jiangsu Rayer Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Rayer Medical Technology Co., Ltd. with the FDA for Image Guidance System For Radiotherapy.

Pre-market Notification Details

Device IDK192405
510k NumberK192405
Device Name:Image Guidance System For Radiotherapy
ClassificationAccelerator, Linear, Medical
Applicant Jiangsu Rayer Medical Technology Co., Ltd. Xishan Economic Development Zone Wuxi,  CN 214192
ContactPeng Li
CorrespondentPeng Li
Jiangsu Rayer Medical Technology Co., Ltd. No. 99 Furongzhongsan Road, Xishan Ecomic Development Zone Wuxi,  CN 214192
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-03
Decision Date2020-05-01

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