Radixact Treatment Delivery System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223159 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 Radixact Treatment Delivery System is a linear accelerator classified as a medical radiation device designed for stereotactic body radiation therapy (SBRT). It delivers precise, high-dose radiation to targeted tumor sites while minimizing exposure to surrounding healthy tissue, enabling accurate treatment planning and delivery across various body regions.
This system is intended for use in radiology settings and incorporates real-time motion tracking and robotic precision for adaptive treatment adjustments. Supplied as a reusable medical device, it requires proper calibration and maintenance in accordance with regulatory standards. The Radixact System holds FDA 510(k) clearance and complies with the Medical Device Directive (MDD), ensuring adherence to safety and performance requirements for radiation therapy equipment.
Frequently asked questions
What types of clinical settings is the Radixact Treatment Delivery System designed for, and what makes it suitable for those environments?
The Radixact Treatment Delivery System is specifically designed for use in radiology settings. Its suitability for these environments comes from its advanced capabilities, such as real-time motion tracking and robotic precision, which enable highly accurate and adaptive radiation therapy. These features are critical for delivering stereotactic body radiation therapy (SBRT) to targeted tumor sites while minimizing exposure to surrounding healthy tissue, ensuring precision and safety in clinical practice.
Is the Radixact Treatment Delivery System intended for single-use or reusable applications, and what maintenance requirements should be considered?
The Radixact Treatment Delivery System is supplied as a reusable medical device. As such, it requires proper calibration and maintenance in accordance with regulatory standards to ensure consistent performance and safety. Regular upkeep is essential to maintain its precision, reliability, and compliance with radiation therapy protocols.
What regulatory pathways has the Radixact Treatment Delivery System followed, and what does this mean for its use in clinical practice?
The Radixact Treatment Delivery System holds FDA 510(k) clearance, indicating it has been deemed substantially equivalent to a legally marketed predicate device. It also complies with the Medical Device Directive (MDD), ensuring it meets stringent safety and performance requirements for radiation therapy equipment. This regulatory clearance means the system is authorized for use in clinical practice under the specified conditions outlined in its approval.
How does the Radixact Treatment Delivery System enhance the precision of radiation therapy compared to traditional methods?
The Radixact Treatment Delivery System enhances precision through its integration of real-time motion tracking and robotic precision, allowing for adaptive adjustments during treatment. This ensures that high-dose radiation is delivered accurately to targeted tumor sites while sparing surrounding healthy tissue, which is particularly valuable in stereotactic body radiation therapy (SBRT) for various body regions.
What does the product code 'IYE' indicate about the Radixact Treatment Delivery System’s classification and intended use?
The product code 'IYE' categorizes the Radixact Treatment Delivery System under the FDA’s classification system for medical devices. While the exact details of this classification are administrative, it aligns with the system’s intended use as a linear accelerator for radiation therapy, specifically within the realm of radiology. This classification helps streamline regulatory processes and ensures the device meets the necessary standards for its intended clinical applications.
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: Radixact Radiation Therapy - Accuray, About Accuray - Radixact, Homepage - Radixact, Radixact Radiotherapy Treatment Resources - Accuray
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 | K223159 | Class II | Active |
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Manufacturer
- Manufacturer
- Accuray Incorporated
Sources (2)
- FDA 510(k) K223159 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026