# K063512: Leksell Gamma Knife Perfexion

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Mar 5, 2007 after 105 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K924849 (1995). 3 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061941: Leksell Gamma Knife Perfexion, Model 715000, Elekta Instrument AB (2006) Summary page 1.

## Most influential descendants
- K120811: Leksell Gamma Knife Perfexion (2012), 7 descendants of its own
- 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

## Recalls of this device
- Nov 6, 2009 · Not classified · Z-1232-2010: There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position.
- Nov 9, 2008 · Not classified · Z-1230-2010: Radiation unit doors could close too fast on emergency exit.
- Jul 2, 2007 · Not classified · Z-1158-2010: Need to modify the closing speed of the shielding doors in the event of an emergency exit
- May 30, 2007 · Not classified · Z-1231-2010: There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate.

## Indications for use
Leksell Gamma Knife®PERFEXION TM is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. metastatic tumors.

Source page: https://510kreport.com/device/K063512
Methodology: https://510kreport.com/methodology