Identifiers
- 510(k) Number
- K150873 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 M6 System is a robotic radiosurgery and stereotactic body radiotherapy (SBRT) device designed for precise delivery of high-dose radiation to tumors throughout the body. It combines linear accelerator technology with robotic mobility to enable targeted treatment while accounting for patient and tumor movement in real time.
This system is used in radiology settings for non-invasive cancer treatment, offering end-to-end sub-millimeter accuracy. It is supplied as a reusable medical device with MRI safety considerations as defined by its regulatory classification. Authorized under FDA 510K and MDD, the CyberKnife M6 System is categorized under product code IYE and regulation number 892.5050, with a review by the Radiology Advisory Committee.
Frequently asked questions
What types of medical facilities primarily use the CyberKnife M6 System, and why is it relevant to their operations?
The CyberKnife M6 System is designed for radiology settings, specifically for non-invasive cancer treatment. Its relevance lies in its ability to deliver precise, high-dose radiation to tumors throughout the body with sub-millimeter accuracy, accounting for patient and tumor movement in real time. This makes it ideal for facilities specializing in advanced radiotherapy, such as radiation oncology centers or hospitals with dedicated radiosurgery programs.
How does the CyberKnife M6 System account for patient movement during treatment, and what does this imply for treatment outcomes?
The CyberKnife M6 System combines linear accelerator technology with robotic mobility to deliver radiation while continuously tracking and adjusting for patient and tumor movement in real time. This ensures that the radiation is precisely targeted to the tumor, minimizing exposure to surrounding healthy tissue and improving the accuracy and effectiveness of the treatment.
Is the CyberKnife M6 System reusable, and what considerations should be taken into account when handling or maintaining it?
Yes, the CyberKnife M6 System is supplied as a reusable medical device. Since it is a complex robotic and radiation delivery system, proper maintenance, calibration, and adherence to manufacturer guidelines are critical to ensure its accuracy, safety, and longevity. Facilities must also follow MRI safety protocols, as the system has specific MRI compatibility considerations.
What regulatory pathways has the CyberKnife M6 System undergone, and what does this mean for its adoption in clinical practice?
The CyberKnife M6 System has been authorized through the FDA 510K pathway and the MDD (Medical Device Directive) in the EU, indicating it has been deemed substantially equivalent to a previously cleared device. This regulatory clearance means it has met the necessary safety and performance standards for use in clinical practice, though adoption still requires compliance with local healthcare regulations and institutional protocols.
How does the CyberKnife M6 System differ from traditional radiation therapy methods in terms of precision and patient experience?
Unlike traditional radiation therapy, which may require immobilization devices and fixed treatment positions, the CyberKnife M6 System uses robotic precision to deliver radiation from multiple angles while tracking movement. This allows for highly targeted, non-invasive treatment with sub-millimeter accuracy, reducing the need for invasive procedures and minimizing side effects for patients by sparing healthy tissue.
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, PDF Cyberknife M6 Series, PDF PRECISE ROBOTIC TREATMENT - accuray.com, Accuray CyberKnife M6 — XRAYN
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 | K150873 | Class II | Active |
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Manufacturer
- Manufacturer
- Accuray Incorporated
Sources (2)
- FDA 510(k) K150873 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026