# K061941: Leksell Gamma Knife Perfexion, Model 715000

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Aug 21, 2006 after 42 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- 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 K924849 (1995). 2 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984328: Leksell Gamma Knife Target System, Model 24001, Elekta Instrument AB (1999) Summary page 1.

## Most influential descendants
- K063512: Leksell Gamma Knife Perfexion (2007), 11 descendants of its own
- 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

## Indications for use
Leksell Gamma Knife® PERFEXION TM is a teletherapy device intended for use in the stereotactic irradiation of intra-cranial structures.

Source page: https://510kreport.com/device/K061941
Methodology: https://510kreport.com/methodology