# K160440: Leksell Gamma Knife Icon

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Apr 20, 2016 after 63 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: 10 generations back to K926449 (1995). 49 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151159: Leksell Gamma Knife Perfexion, Elekta Instrument AB (2015) Summary page 4.
- K151561: Leksell Gamma Knife Icon, Elekta Instrument AB (2015) Summary page 4.

## Most influential descendants
- 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
- May 23, 2017 · Class II · Z-2697-2017: If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing maintenance on the

## 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 ∙ Recurrent glioblastomas ∙ Trigeminal neuralgia ∙ Medically refractory essential tremor ∙ Orbital tumors ∙ Ocular tumors ∙ Optic nerve tumors ∙ Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas) ∙ Skull base tumors ∙ Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland) ∙ Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).

Source page: https://510kreport.com/device/K160440
Methodology: https://510kreport.com/methodology