# K241937: Klarity SGRT System (ARSG-E1A, ARSG-E3A)

- Pathway: 510(k) (Traditional)
- Applicant: Klarity Medical & Equipment (GZ) Co., Ltd.
- Decided: Mar 18, 2025 after 259 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 K864886 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113276: Catalyst, C-Rad Positioning AB (2012) Summary page 5.

## Indications for use
With radiotherapy equipment (Medical Linac, CT-Sim), it is used for patient positioning before treatment and continuous monitoring of patients during treatment, and can also be used to track patients' breathing mode (including DIBH, EEBH, 4DCT three breathing modes), in order to implement image acquisition synchronized with breathing and radiation therapy.

Source page: https://510kreport.com/device/K241937
Methodology: https://510kreport.com/methodology