# K952291: Gammacell 3000 Elan

- Pathway: 510(k) (Traditional)
- Applicant: Nordion International, Inc.
- Decided: Aug 25, 1995 after 101 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.
2 later devices descend 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K963497: Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0 (1996), 1 descendant of its own
- K050963: Gammacell 1000 Elite and Gammacell 3000 Elan (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K952291
Methodology: https://510kreport.com/methodology