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Radixact Treatment Delivery System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K161146

by Accuray Incorporated

Identifiers

510(k) Number
K161146 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 designed for radiation therapy, classified as a medical accelerator. It delivers precise, high-dose radiation treatments to target tumors while minimizing exposure to surrounding healthy tissue, enabling conformal and stereotactic body radiation therapy (SBRT).

This system is intended for use in radiology departments and is supplied as a reusable, non-sterile medical device. It incorporates real-time imaging and robotic precision for adaptive treatment planning and delivery. The device operates under FDA 510(k) clearance and adheres to the Medical Device Directive (MDD), with regulatory classification as a Class II device. No MRI compatibility or single-use specifications are noted.

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, Homepage - Radixact, About Accuray - Radixact, Radixact Radiotherapy Treatment Resources - Accuray

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Accuray Incorporated

Sources (2)

  • FDA 510(k) K161146 24 fields · synced Sep 20, 2026
  • EUDAMED 1 fields · synced May 29, 2026