# K051022: Gammaplan

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Jun 1, 2005 after 40 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K914808 (1992). 3 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973441: Leksell Gammaplan, Patterson Consulting Group, Inc. (1998) Summary page 1.
- K042269: Leksell Gammaplan 4C with Multiview, Elekta Instrument AB (2004) Summary page 1.

## Most influential descendants
- K061540: Leksell Gammaplan (2006), 9 descendants of its own
- K090972: Leksell Gammaplan (2009), 6 descendants of its own
- K103093: Leksell Gammaplan (2010), 5 descendants of its own
- K151666: Leksell GammaPlan (2015), 4 descendants of its own
- K173791: Leksell GammaPlan (2018), 3 descendants of its own

## Indications for use
GammaPlan® is a computer-based system designed for Gamma Knife® treatment planning.

Source page: https://510kreport.com/device/K051022
Methodology: https://510kreport.com/methodology