Leksell Gamma Knife Perfexion, Model 715000
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061941 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, Model 715000, is a stereotactic radiosurgery system designed for precise delivery of ionizing radiation to intracranial targets. Classified as a radiation therapy device, it employs a radionuclide-based approach to treat complex neurological conditions with high accuracy. This system is engineered to minimize invasiveness while maximizing therapeutic precision for conditions such as tumors, vascular malformations, and functional disorders.
The device comprises a radiation unit, patient positioning system, and an operator console with control panel and computer. Supplied as a reusable medical system, it requires specialized installation and maintenance in a radiology setting. The Leksell Gamma Knife Perfexion, Model 715000, holds FDA 510(k) clearance under the Radiology advisory committee and is categorized under product code IWB. Compliance with regulatory standards ensures safe and effective use in clinical environments.
Frequently asked questions
What is the Leksell Gamma Knife Perfexion 715000 used for?
The Leksell Gamma Knife Perfexion 715000 is designed for stereotactic radiosurgery, providing highly accurate delivery of ionizing radiation to treat complex neurological conditions. This includes intracranial tumors, vascular malformations, and functional disorders. Its radionuclide-based approach ensures targeted precision while minimizing invasiveness, making it suitable for delicate brain procedures.
How is the Leksell Gamma Knife Perfexion 715000 supplied and installed?
This system is supplied as a reusable medical device and requires specialized installation in a radiology setting. It consists of a radiation unit, patient positioning system, and an operator console with a control panel and computer. Due to its complexity, proper setup and maintenance must be performed by trained professionals to ensure safe and effective operation.
Is the Leksell Gamma Knife Perfexion 715000 single-use or reusable?
The Leksell Gamma Knife Perfexion 715000 is designed as a reusable medical device. Its components, including the radiation unit and patient positioning system, are engineered for repeated use under strict maintenance protocols. This ensures long-term reliability and cost-effectiveness in clinical environments.
What regulatory clearance does the Leksell Gamma Knife Perfexion 715000 hold?
The device holds FDA 510(k) clearance under the Radiology advisory committee, categorized under product code IWB. This clearance confirms its substantial equivalence to a previously approved device, ensuring compliance with regulatory standards for radiation therapy systems in the U.S. market.
What are the key components of the Leksell Gamma Knife Perfexion 715000?
The system comprises three primary components: the radiation unit (which delivers the ionizing radiation), the patient positioning system (to ensure precise alignment), and the operator console (featuring a control panel and computer for treatment planning and execution). These components work together to enable accurate and controlled radiosurgical interventions.
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, LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 (K061941) — FDA 510(k ..., PDF Leksell Gamma Knife Perfexion - Preferred for a reason
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061941 | Class II | Active |
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Manufacturer
- Manufacturer
- Elekta Instrument AB
Sources (1)
- FDA 510(k) K061941 24 fields · synced Oct 1, 2026