# K120811: Leksell Gamma Knife Perfexion

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: May 24, 2012 after 69 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- 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: 4 generations back to K924849 (1995). 4 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063512: Leksell Gamma Knife Perfexion, Elekta Instrument AB (2007) Summary page 1.

## Most influential descendants
- K133565: Leksell Gamma Knife Perfexion (2014), 6 descendants of its own
- K151159: Leksell Gamma Knife Perfexion (2015), 4 descendants of its own
- K151561: Leksell Gamma Knife Icon (2015), 4 descendants of its own
- K160440: Leksell Gamma Knife Icon (2016), 3 descendants of its own
- K173789: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (2018), 2 descendants of its own

## Recalls of this device
- Oct 6, 2014 · Class II · Z-0152-2015: Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.

## Indications for use
Leksell Gamma Knife® Perfexion is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters eag. metastatic tumors, arteriovenous malformations, trigemninal neuralgia, meningiomas and vestibular schwannomas.

Source page: https://510kreport.com/device/K120811
Methodology: https://510kreport.com/methodology