Identifiers
- 510(k) Number
- K061540 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 GammaPlan is a computer-based treatment planning system classified as a Radiation Therapy, Radionuclide System under the FDA’s nomenclature. It is designed to calculate and optimize radiation dose distributions for stereotactic radiosurgery, particularly intracranial procedures, by integrating with the Leksell Gamma Knife system. The software provides specialized algorithms to ensure precise targeting and conformal dose delivery while minimizing exposure to surrounding healthy tissue.
Leksell GammaPlan is supplied as a standalone software solution, intended for use in radiology departments or dedicated stereotactic radiosurgery centers. It operates as a Software as a Medical Device (SaMD) and is classified under FDA Class II, with clearance granted via a 510(k) Special Review under the Radiology Advisory Committee. The system is not single-use or reusable in a clinical hardware sense but relies on the associated Leksell Gamma Knife hardware for execution. No sterility or MRI safety classifications are specified in the regulatory data.
Frequently asked questions
What is the Leksell GammaPlan primarily used for in clinical settings?
The Leksell GammaPlan is a specialized Software as a Medical Device (SaMD) designed to calculate and optimize radiation dose distributions for stereotactic radiosurgery, particularly for intracranial (brain) procedures. It integrates with the Leksell Gamma Knife system to ensure precise targeting and conformal dose delivery, helping minimize exposure to healthy tissue surrounding the treatment area.
How is the Leksell GammaPlan supplied, and is it reusable or single-use?
The Leksell GammaPlan is supplied as a standalone software solution and is not a physical device in the traditional sense. Since it is software-based, it is neither single-use nor reusable in the clinical hardware sense—it operates on compatible hardware (the Leksell Gamma Knife system) and requires no physical disposal or reprocessing. The system itself is not sterilized or classified for reuse.
What regulatory pathway was followed for the Leksell GammaPlan’s clearance, and which advisory committee was involved?
The Leksell GammaPlan received FDA clearance via a 510(k) Special Review, classified under Radiation Therapy, Radionuclide System (Product Code: IWB) and FDA Class II. The review was conducted under the Radiology Advisory Committee (RA), reflecting its specialized use in radiology departments and stereotactic radiosurgery centers.
Does the Leksell GammaPlan require any specific hardware to function, and where is it intended for use?
Yes, the Leksell GammaPlan is designed to integrate with the Leksell Gamma Knife hardware system—it is not a standalone physical device but a software tool that relies on this equipment for execution. It is intended for use in radiology departments or dedicated stereotactic radiosurgery centers, where precise radiation planning for intracranial procedures is performed.
Are there any special handling or storage requirements for the Leksell GammaPlan software?
Since the Leksell GammaPlan is a software-based system, its primary requirements revolve around compatible hardware infrastructure (e.g., the Leksell Gamma Knife system) and IT compliance (e.g., network security, system updates). Unlike physical devices, it does not require sterilization, refrigeration, or specialized storage conditions. However, adherence to the manufacturer’s technical specifications (e.g., operating system requirements, hardware compatibility) is critical for proper functionality.
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, PDF Elekta Instrument AB
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061540 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elekta Instrument AB
Sources (1)
- FDA 510(k) K061540 24 fields · synced Sep 19, 2026