Leksell Gamma Knife Perfexion
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151159 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 Perfexion is a radiosurgery system classified as a Radiation Therapy, Radionuclide device under the FDA’s nomenclature. It delivers precise, high-dose ionizing radiation to intracranial targets using multiple gamma-ray beams, enabling non-invasive treatment of functional and neoplastic conditions in the brain.
This system is designed for use in radiology settings and is supplied as a reusable medical device. It operates under FDA 510(k) clearance (K151159) and is intended for single-patient procedures, with no indication of MRI compatibility or sterility requirements specified in the data. Storage and handling follow manufacturer guidelines to maintain performance and safety.
Frequently asked questions
What types of brain conditions can the Leksell Gamma Knife Perfexion treat, and how does it work?
The Leksell Gamma Knife Perfexion is designed for non-invasive treatment of functional and neoplastic (tumor-related) conditions in the brain. It delivers highly precise, high-dose ionizing radiation using multiple gamma-ray beams to target specific intracranial areas, effectively treating conditions without traditional surgery. This approach is particularly useful for conditions requiring focused radiation therapy in radiology settings.
Is the Leksell Gamma Knife Perfexion a single-use or reusable device, and how should it be stored?
The Leksell Gamma Knife Perfexion is a reusable medical device, meaning it is intended for use across multiple procedures. Storage and handling must follow the manufacturer’s guidelines to ensure performance and safety, though no specific sterility requirements are mentioned in the data. Proper maintenance is critical for its continued functionality.
What regulatory pathway was followed for FDA clearance of the Leksell Gamma Knife Perfexion, and what classification does it hold?
The Leksell Gamma Knife Perfexion received FDA clearance through a Traditional 510(k) pathway (K151159) and is classified as a Radiation Therapy, Radionuclide device under FDA nomenclature. It was reviewed by the Radiology (RA) Advisory Committee and is categorized as a Class II device, indicating it carries moderate risk and requires special controls to ensure safety and effectiveness.
Does the Leksell Gamma Knife Perfexion have any compatibility limitations, such as MRI use?
The provided data does not specify MRI compatibility for the Leksell Gamma Knife Perfexion. Clinicians should consult the manufacturer’s instructions for use to determine if the system can be safely used in MRI environments or if any restrictions apply. Compatibility with other imaging modalities is not addressed in the available information.
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® Perfexion™ - Elekta, 3. Leksell Gamma Knife® Perfexion™ - Elekta, PDF ELEKTA ELEKTA INSTRUMENT AB AB f INSTRUMENT 5 - Food and Drug ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151159 | Class II | Active |
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Manufacturer
- Manufacturer
- Elekta Instrument AB
Sources (1)
- FDA 510(k) K151159 24 fields · synced Sep 19, 2026