CyberKnife Robotic Radiosurgery System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K062514 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)
The CyberKnife Robotic Radiosurgery System is a radiation therapy treatment system that delivers radiosurgery treatments with sub-millimeter accuracy. It features a linear accelerator mounted on a robot for precise, frameless, and non-invasive treatment delivery, utilizing coplanar and non-coplanar, isocentric and non-isocentric beam delivery methods. The system provides real-time correction for positional and anatomical changes during treatment.
The device is supplied as a reusable system for use in clinical settings such as radiotherapy centers. It is authorized under FDA 510(k) clearance (K062514) and classified as a Class II medical device under regulation number 892.5050. The system is intended for use in radiation therapy treatment planning and delivery, with no claims made regarding sterility, single-use status, MRI safety, or storage conditions in the provided data.
Frequently asked questions
What is the CyberKnife Robotic Radiosurgery System used for?
The CyberKnife Robotic Radiosurgery System is used for radiation therapy treatment planning and delivery, providing frameless and non-invasive radiosurgery with sub-millimeter accuracy to treat tumors using coplanar and non-coplanar beam delivery methods.
Is the CyberKnife system reusable or single-use?
The CyberKnife Robotic Radiosurgery System is supplied as a reusable system intended for use in clinical settings such as radiotherapy centers, meaning it is designed for multiple treatments after proper reprocessing between uses.
Does the CyberKnife system require sterility or have specific storage conditions?
The provided data does not include any claims regarding sterility, single-use status, or specific storage conditions for the CyberKnife Robotic Radiosurgery System, so these aspects are not addressed in the authorization documentation.
How does the CyberKnife system ensure accuracy during treatment?
The system provides real-time correction for positional and anatomical changes during treatment by using a linear accelerator mounted on a robot, enabling precise, frameless radiation delivery with sub-millimeter accuracy through advanced image-guided targeting.
What regulatory pathway was used for the CyberKnife system?
The CyberKnife Robotic Radiosurgery System received FDA 510(k) clearance under submission number K062514, indicating it was found substantially equivalent to a legally marketed predicate device.
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 SRS / SBRT System from Accuray, Home - CyberKnife, CyberKnife Radiosurgery - accuray.com, CyberKnife - How it Works - CyberKnife, About Accuray - CyberKnife
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062514 | Class II | Active |
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Manufacturer
- Manufacturer
- Accuray Incorporated
Sources (1)
- FDA 510(k) K062514 24 fields · synced Sep 21, 2026