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FDA 510(k)

Image Guidance System for Radiotherapy

K-Number: K192405 · 2020-05-01

ApplicantJiangsu Rayer Medical Technology Co., Ltd.
Decision Date2020-05-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Image Guidance System for Radiotherapy is a medical device manufactured by Jiangsu Rayer Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-01 under approval number K192405. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Image Guidance System for Radiotherapy?

Image Guidance System for Radiotherapy is a medical device that received FDA 510(k) clearance on 2020-05-01. It is manufactured by Jiangsu Rayer Medical Technology Co., Ltd.. The 510(k) number is K192405.

When was Image Guidance System for Radiotherapy approved by the FDA?

Image Guidance System for Radiotherapy received FDA 510(k) clearance on 2020-05-01, under approval number K192405.

What company makes Image Guidance System for Radiotherapy?

Image Guidance System for Radiotherapy is manufactured by Jiangsu Rayer Medical Technology Co., Ltd..

What is the FDA product code for Image Guidance System for Radiotherapy?

The FDA product code for Image Guidance System for Radiotherapy is IYE.

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Official Source

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