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Leksell GammaPlan

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151666

by Elekta Instrument AB

Identifiers

510(k) Number
K151666 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)

Leksell GammaPlan is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife. It is a treatment planning and management software that provides specialized tools for intracranial radiosurgery, ensuring safe and efficient workflows.

The device is supplied by Elekta Instrument AB and is a Software as Medical Device (SaMD). It has received FDA 510(k) clearance with the product code MUJ and is classified as a System for Planning Radiation Therapy Treatment. The device is intended for use with Leksell Gamma Knife systems and includes optional encryption for patient data protection.

Frequently asked questions

What is Leksell GammaPlan used for?

Leksell GammaPlan is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife. It provides specialized tools for intracranial radiosurgery, ensuring safe and efficient treatment planning and management workflows.

How is Leksell GammaPlan supplied and what are its regulatory approvals?

Leksell GammaPlan is supplied by Elekta Instrument AB as a Software as Medical Device (SaMD). It has received FDA 510(k) clearance with the product code MUJ and is classified as a System for Planning Radiation Therapy Treatment.

What data protection features does Leksell GammaPlan offer?

Leksell GammaPlan includes optional encryption for patient data protection, ensuring that sensitive medical information remains secure during the treatment planning process.

Is Leksell GammaPlan compatible with other radiation therapy systems?

Leksell GammaPlan is specifically intended for use with Leksell Gamma Knife systems and is not designed for use with other radiation therapy equipment.

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® | Stereotactic Radiosurgery | Elekta, LEKSELL GAMMAPLAN by ELEKTA INSTRUMENT AB | FDA 510(k) Summary, LEKSELL GAMMAPLAN by ELEKTA INSTRUMENT AB | FDA 510(k) Summary

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) K151666 24 fields · synced Sep 25, 2026