# K192405: Image Guidance System for Radiotherapy

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Rayer Medical Technology Co., Ltd.
- Decided: May 1, 2020 after 241 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K963624 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120789: Exactrac X-Ray X-Ray, Brainlab AG (2012) Summary page 6.

## Indications for use
Image Guidance System for Radiotherapy is intended to be used in combination with the radiotherapy device, for image-guided positioning verification and real-time tracking of target motion for patient radiation therapy. The Image Guidance System for Radiotherapy sends the positioning data or real-time tracking data to the radiotherapy device but does not control any part of the radiotherapy device.

Source page: https://510kreport.com/device/K192405
Methodology: https://510kreport.com/methodology