# K161324: Raycell Mk2

- Pathway: 510(k) (Special)
- Applicant: Best Theratronics Limited
- Decided: Aug 12, 2016 after 93 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: 1 generation back to K051065 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051065: Raycell X-Ray Blood Irradiator, Mds Nordion (2005) Summary page 4.

## Most influential descendants
- K181737: Raycell MK1 (2019), 0 descendants of its own

## Indications for use
The Raycell 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/K161324
Methodology: https://510kreport.com/methodology