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Leksell Gamma Knife Icon

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151561

by Elekta Instrument AB

Identifiers

510(k) Number
K151561 FDA 510(k)
FDA Product Code
IWB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5750 FDA 510(k)
Regulation Number
892.5750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Leksell Gamma Knife Icon is a stereotactic radiosurgery system designed for intracranial radiation therapy. It delivers precisely targeted radiation to lesions in the brain while sparing surrounding healthy tissue. The system is classified under radiation therapy, radionuclide, and is associated with radiology as its medical specialty.

The device is used in clinical settings for non-invasive brain treatments and is supplied by Elekta Instrument AB. It is a single-use or integrated system depending on component configuration, and sterility is maintained per manufacturer guidelines. Storage conditions and handling instructions are provided by the manufacturer, and the device is regulated under FDA 510(k) clearance with substantially equivalent determination.

Frequently asked questions

What is the Leksell Gamma Knife Icon used for?

The Leksell Gamma Knife Icon is a stereotactic radiosurgery system designed for intracranial radiation therapy. It is used to deliver precisely targeted radiation to brain lesions while sparing surrounding healthy tissue, supporting non-invasive clinical treatments.

How is the device supplied and handled?

The device is supplied by Elekta Instrument AB and is configured as a single-use or integrated system depending on component setup. Sterility is maintained according to manufacturer guidelines, and specific storage conditions and handling instructions are provided by the manufacturer.

What is the regulatory status of this device?

The Leksell Gamma Knife Icon is regulated under FDA 510(k) clearance with a substantially equivalent determination. It was cleared under traditional review with advisory committee input from Radiology, reflecting its classification in radiation therapy and radionuclide systems.

What medical specialty is associated with this device?

The device is associated with radiology as its medical specialty, consistent with its use in imaging-guided, non-invasive brain treatments. The advisory committee review was conducted under the Radiology (RA) panel.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Leksell Gamma Knife® Icon™ - elekta.com, 2. Leksell Gamma Knife® Icon™ - Elekta, Leksell Gamma Knife® Icon™ - Elekta - PDF Catalogs - MedicalExpo, PDF Leksell Gamma Knife Icon

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Elekta Instrument AB

Sources (1)

  • FDA 510(k) K151561 24 fields · synced Sep 27, 2026