# K050963: Gammacell 1000 Elite and Gammacell 3000 Elan

- Pathway: 510(k) (Special)
- Applicant: Mds Nordion
- Decided: May 20, 2005 after 32 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 K952291 (1995). 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)
- K963497: Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0, Nordion International, Inc. (1996) Summary page 1.

## Indications for use
To irradiate cellular blood products to inactivate T-lymphocytes in order to prevent graft versus host disease.

Source page: https://510kreport.com/device/K050963
Methodology: https://510kreport.com/methodology