Image Guidance System for Radiotherapy

FDA 510(k) K192405 · Jiangsu Rayer Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK192405

Submission

Device name
Image Guidance System for Radiotherapy
Applicant
Jiangsu Rayer Medical Technology Co., Ltd.
Wuxi, CN
Received
September 3, 2019
Decision date
May 1, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

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

Image Guidance System for Radiotherapy (K192405) received a 510(k) decision of Substantially Equivalent on May 1, 2020, 241 days after the submission was received.

What is the product code of K192405?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.