# K042269: Leksell Gammaplan 4C with Multiview

- Pathway: 510(k) (Special)
- Applicant: Elekta Instrument AB
- Decided: Sep 8, 2004 after 16 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K914808 (1992). 2 ancestors in all.
11 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.

## Most influential descendants
- K051022: Gammaplan (2005), 10 descendants of its own
- 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

## Indications for use
The Leksell GarmmaPlan 4C with MultiView is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife®. The Leksell GammaPlan 4C with MultiView is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgey and stereotactic radio therapy. It processes the inputs from the healt care professionals such that the desired radiation dose is provided by the Leksell Gamma Knife® to a precisely defined target area within the cranium.

Source page: https://510kreport.com/device/K042269
Methodology: https://510kreport.com/methodology