# K103093: Leksell Gammaplan

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Dec 21, 2010 after 63 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: 6 generations back to K914808 (1992). 30 ancestors in all.
5 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)
- K090972: Leksell Gammaplan, Elekta Instrument AB (2009) Summary page 1.
- K092132: Xio RTP System, Computerized Medical Systems, Inc. (2009) Summary page 1.

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

## Recalls of this device
- Jun 1, 2015 · Class II · Z-1719-2015: Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.

## 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/K103093
Methodology: https://510kreport.com/methodology