# K151666: Leksell GammaPlan

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Sep 3, 2015 after 76 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K914808 (1992). 31 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K103093: Leksell Gammaplan, Elekta Instrument AB (2010) Summary page 4.

## Most influential descendants
- K173791: Leksell GammaPlan (2018), 3 descendants of its own
- 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-1339-2026: 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

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

Source page: https://510kreport.com/device/K151666
Methodology: https://510kreport.com/methodology