# K201177: RadGil2

- Pathway: 510(k) (Traditional)
- Applicant: R3 X-Ray L.L.C
- Decided: Aug 17, 2020 after 108 days
- Product code: MOT (Irradiator, Blood To Prevent Graft Versus Host Disease)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K865027 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172087: Sangray, Hitachi, Ltd. (2017) Summary page 4.

## Indications for use
RadGil2 US is an X-Ray irradiation device intended for use in the irradiation of blood and blood products packaged in transfusion bags to inactivate lymphocytes for the prevention of graft vs host disease (GVHD)

Source page: https://510kreport.com/device/K201177
Methodology: https://510kreport.com/methodology