# K051065: Raycell X-Ray Blood Irradiator

- Pathway: 510(k) (Special)
- Applicant: Mds Nordion
- Decided: May 26, 2005 after 30 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K172087: Sangray (2017), 1 descendant of its own
- K161324: Raycell Mk2 (2016), 1 descendant of its own
- K201177: RadGil2 (2020), 0 descendants of its own
- K181737: Raycell MK1 (2019), 0 descendants of its own

## Indications for use
The RaycellTM X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease according to applicable FDA, AABB, Health Canada, and European guidelines. The Raycell'" X-ray Blood Irradiator is also intended for use in the irradiation of intra-operatively salvaged blood for cancer patients undergoing surgery to assist in the prevention of metastasis.

Source page: https://510kreport.com/device/K051065
Methodology: https://510kreport.com/methodology