Leksell Gamma Knife Icon— 510(k) K160440

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K160440 for Leksell Gamma Knife Icon, Substantially Equivalent on 2016-04-20. Applicant: Elekta Instrument AB. Device class: 2.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2016-02-17
Decision date: 2016-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code IWB

K250391 — Leksell Gamma Knife® (3 models)2025-07-02
K232854 — Leksell GammaPlan (LGP)2024-02-08
K222047 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)2022-10-26
K203250 — TaiChiC2021-03-12
K203146 — Akesis Galaxy RTi2021-03-05

More clearances from Elekta Instrument AB

K190887 — Leksell Vantage Stereotactic System2019-08-01
K173789 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon2018-03-30
K173791 — Leksell GammaPlan2018-02-09
K171123 — Leksell Vantage Stereotactic System2017-09-15
K152558 — Leksell Stereotactic System, Injection/ Aspiration Needle Kit2016-03-02

Recalls naming K160440

K-number listed on FDA's recall record

Z-2697-2017 — 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), and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).Class II·Terminated·Elekta, Inc.·20170523

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160440.

Data sourced from openFDA. This site is unofficial and independent of the FDA.