# K963497: Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Nordion International, Inc.
- Decided: Nov 8, 1996 after 66 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 K952291 (1995). 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)
- K952291: Gammacell 3000 Elan, Nordion International, Inc. (1995) Summary page 1.

## Most influential descendants
- K050963: Gammacell 1000 Elite and Gammacell 3000 Elan (2005), 0 descendants of its own

## Indications for use
The intended use of the modified Gammacell with version 1.0 control system remains unchanged. Both the improved and the predicate device effectively irradiate blood and blood components to inactivate leukocytes and lymphocytes.

Source page: https://510kreport.com/device/K963497
Methodology: https://510kreport.com/methodology