# K061540: Leksell Gammaplan

- Pathway: 510(k) (Special)
- Applicant: Elekta Instrument AB
- Decided: Jul 5, 2006 after 30 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: 4 generations back to K914808 (1992). 4 ancestors in all.
9 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)
- K051022: Gammaplan, Elekta Instrument AB (2005)
- K973441: Leksell Gammaplan, Patterson Consulting Group, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K193459: Panther Stereotactic (2020), 1 descendant of its own

## Indications for use
Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®.

Source page: https://510kreport.com/device/K061540
Methodology: https://510kreport.com/methodology