# K173791: Leksell GammaPlan

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Feb 9, 2018 after 57 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K914808 (1992). 32 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151666: Leksell GammaPlan, Elekta Instrument AB (2015) Summary page 4.

## Most influential descendants
- K193459: Panther Stereotactic (2020), 1 descendant of its own
- K232854: Leksell GammaPlan (LGP) (2024), 0 descendants of its own
- K231825: Panther TPS (2023), 0 descendants of its own

## Recalls of this device
- Dec 12, 2025 · Class II · Z-1340-2026: Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that poten
- Jun 27, 2018 · Class II · Z-1412-2019: The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.

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

Source page: https://510kreport.com/device/K173791
Methodology: https://510kreport.com/methodology