# K151561: Leksell Gamma Knife Icon

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Aug 4, 2015 after 55 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: 9 generations back to K926449 (1995). 42 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133565: Leksell Gamma Knife Perfexion, Elekta Instrument AB (2014) Summary page 4.
- K131965: XVI R5.0, Elekta Limited (2013) Summary page 4.

## Most influential descendants
- 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
- K222047: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) (2022), 1 descendant of its own
- K250391: Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) (2025), 0 descendants of its own

## Recalls of this device
- Apr 19, 2016 · Class II · Z-1561-2016: The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.

## Indications for use
Leksell Gamma Knife® Icon™ 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, arteriovenous malformations, trigeminal neuralgia, medically refractory essential tremor, meningiomas, vestibular schwannomas, post-surgical pituitary adenomas and recurrent glioblastomas.

Source page: https://510kreport.com/device/K151561
Methodology: https://510kreport.com/methodology