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Leksell GammaPlan

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103093

by Elekta Instrument AB

Identifiers

510(k) Number
K103093 FDA 510(k)
FDA Product Code
MUJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Leksell GammaPlan is a Computer-Based Dose Planning System (Device Class II) designed for stereotactic radiosurgery treatment planning. It integrates with the Leksell Gamma Knife system to deliver precise radiation therapy for intracranial targets, enabling clinicians to calculate and optimize dose distributions with specialized algorithms tailored for radiosurgical workflows.

This software is intended for use in radiation oncology settings and is supplied as a standalone system for treatment planning. It is not single-use and requires compatibility with the Leksell Gamma Knife system. The device holds FDA 510(k) clearance (K103093) under the Radiology Advisory Committee and adheres to regulatory requirements for medical imaging and radiation therapy planning systems. No sterility or MRI safety classifications are specified.

Frequently asked questions

What is the Leksell GammaPlan primarily used for in a clinical setting?

The Leksell GammaPlan is a Computer-Based Dose Planning System specifically designed for stereotactic radiosurgery treatment planning. It integrates with the Leksell Gamma Knife system to help clinicians calculate and optimize radiation dose distributions for intracranial targets, ensuring precise delivery of radiation therapy in radiation oncology settings.

Is the Leksell GammaPlan a single-use device, or can it be reused?

The Leksell GammaPlan is not a single-use device. It is supplied as a standalone system for treatment planning and is intended to be used repeatedly in radiation oncology settings, provided it remains compatible with the Leksell Gamma Knife system.

What regulatory pathway was followed for FDA clearance of the Leksell GammaPlan?

The Leksell GammaPlan received FDA clearance through a 510(k) submission, specifically under the Radiology Advisory Committee (RA). The clearance type is traditional, and the device was determined to be substantially equivalent to a predicate. The clearance number is K103093.

Does the Leksell GammaPlan require any specific compatibility with other systems to function?

Yes, the Leksell GammaPlan is designed to integrate with the Leksell Gamma Knife system. It is not a standalone device for standalone use but rather a complementary software system for treatment planning within the radiosurgery workflow.

Are there any special handling requirements for the Leksell GammaPlan, such as sterility or MRI safety?

The Leksell GammaPlan does not specify any sterility requirements or MRI safety classifications. Since it is a software-based system for treatment planning, these considerations do not apply in the same way as they would for physical medical devices.

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 GammaPlan® | Stereotactic Radiosurgery | Elekta, Leksell GammaPlan® - Elekta, LEKSELL GAMMAPLAN by ELEKTA INSTRUMENT AB | FDA 510(k) Summary, Leksell GammaPlan (LGP) (K232854) — FDA 510(k) | Innolitics

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) K103093 24 fields · synced Sep 19, 2026