CyberKnife Robotic Radiosurgery System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K072504 FDA 510(k)
- FDA Product Code
- IYE 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 CyberKnife Robotic Radiosurgery System is a robotic radiosurgery device designed for precise, non-invasive delivery of high-dose radiation to treat tumors and other abnormalities. It combines a linear accelerator with robotic positioning to target complex geometries with sub-millimeter accuracy, enabling treatment of both intracranial and extracranial lesions.
This system is used in radiology settings for stereotactic radiosurgery and radiotherapy, delivering radiation without the need for invasive surgery. It is supplied as a reusable medical device with FDA 510(k) clearance and MDD authorization, adhering to regulatory standards for radiation-emitting equipment. The system operates in non-sterile environments and requires specialized training for operation and maintenance.
Frequently asked questions
What types of medical facilities or departments would typically use the CyberKnife Robotic Radiosurgery System, and why?
The CyberKnife Robotic Radiosurgery System is designed for use in radiology departments within hospitals or specialized radiation oncology centers. It is specifically intended for non-invasive treatment of tumors and abnormalities, both intracranial (brain) and extracranial (outside the brain), using precise radiation delivery. Its robotic precision and stereotactic capabilities make it ideal for complex cases where traditional surgery or radiation methods may be less effective or more invasive.
Is the CyberKnife Robotic Radiosurgery System intended for single-use or reusable applications, and what does this mean for maintenance?
The CyberKnife Robotic Radiosurgery System is supplied as a reusable medical device, meaning it is designed for repeated use after proper cleaning, maintenance, and sterilization procedures. This requires specialized training for operators and maintenance staff to ensure the system remains functional, accurate, and compliant with regulatory standards for radiation-emitting equipment.
How is the CyberKnife system regulated, and what does this imply for its adoption in clinical settings?
The CyberKnife Robotic Radiosurgery System holds FDA 510(k) clearance and MDD authorization, indicating it has undergone regulatory review to demonstrate substantial equivalence to previously cleared devices. This implies it has met stringent safety and performance standards for radiation-emitting equipment, allowing its adoption in clinical settings where precision radiosurgery is required, though local institutional approvals and training may still apply.
Does the CyberKnife system require sterile conditions for operation, and how does this affect its use in clinical environments?
The CyberKnife Robotic Radiosurgery System is not designed for sterile environments—it operates in non-sterile settings. This means it is not intended for direct patient contact in sterile procedures but is instead used in controlled radiology environments where precision radiation delivery is prioritized over sterility, such as in radiosurgery or radiotherapy treatments.
What types of tumors or abnormalities can the CyberKnife system treat, and how does its robotic precision contribute to its effectiveness?
The CyberKnife system is designed to treat tumors and abnormalities with complex geometries, including both intracranial (brain) and extracranial (body-wide) lesions. Its robotic precision allows for sub-millimeter accuracy in radiation delivery, enabling targeted treatment of delicate or hard-to-reach areas while minimizing exposure to surrounding healthy tissue, which enhances its effectiveness for cases where traditional surgery or radiation may be less precise.
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: CyberKnife - How it Works - CyberKnife, Home - CyberKnife, Cyberknife: Klinik für Radioonkologie und Strahlentherapie - Charité ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K072504 | Class II | Active |
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Manufacturer
- Manufacturer
- Accuray Incorporated
Sources (2)
- FDA 510(k) K072504 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026