# K172087: Sangray

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi, Ltd.
- Decided: Oct 27, 2017 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: 3 generations back to K865027 (1987). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082921: Rad Source X-Ray Blood Irradiator, Model RS-3400, Rad Source Technologies, Inc. (2009) Summary page 4.
- K051065: Raycell X-Ray Blood Irradiator, Mds Nordion (2005) Summary page 4.

## Most influential descendants
- K201177: RadGil2 (2020), 0 descendants of its own

## Indications for use
The SANGRAY is an x-ray irradiation system intended for use in the irradiation of blood and blood products packaged in transfusion bags to inactivate lymphocytes for the prevention of graft versus host disease (GVHD).

Source page: https://510kreport.com/device/K172087
Methodology: https://510kreport.com/methodology