# K032684: Raycell

- Pathway: 510(k) (Special)
- Applicant: Mds Nordion
- Decided: Sep 26, 2003 after 28 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: 2 generations back to K865027 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974210: Shielded Cabinet X-Ray Radiation Source Device Model RS 3000, Rad-Source, Inc. (1998) Summary page 2.

## Indications for use
The RaycellTM Cabinet X-ray System is intended for the irradiation of blood and blood products packaged in transfusion bags when irradiation to reduce the risk of Graft versus Host Disease is indicated, and is used in accordance with “Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products” (22 July 1993 memorandum from Acting Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA to all registered blood establishments).

Source page: https://510kreport.com/device/K032684
Methodology: https://510kreport.com/methodology