Varian Treatment (VTx)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151882 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 Varian Treatment (VTx) is a software-based treatment delivery management application designed to interface between oncology information systems and external radiation therapy delivery systems, such as linear accelerators. It facilitates the coordination and automation of radiotherapy workflows, ensuring precise and efficient treatment planning and execution in clinical settings.
VTx is supplied as a software solution, intended for use in radiology departments and cancer treatment centers. It operates as a reusable, non-sterile system, requiring integration with existing radiation therapy equipment and oncology information systems. The device is regulated under FDA 510(k) clearance (K151882) and adheres to the Medical Device Regulation (MDR) framework, with a product code classification of IYE. No specific MRI safety or sterility requirements are noted for the software itself, as it is not a physical medical device.
Frequently asked questions
What is the primary purpose of the Varian Treatment (VTx) software in a clinical setting?
The Varian Treatment (VTx) is designed to act as a software-based bridge between oncology information systems and external radiation therapy delivery systems, such as linear accelerators. Its main purpose is to streamline and automate radiotherapy workflows, ensuring precise coordination and execution of treatment plans in radiology departments and cancer treatment centers.
Is the Varian Treatment (VTx) a single-use or reusable device, and what does this mean for its maintenance?
The VTx is a reusable, non-sterile software solution, meaning it is not intended for single-use disposal. Since it is not a physical medical device requiring sterilization, maintenance focuses on software updates, system integration checks, and ensuring compatibility with existing radiation therapy equipment and oncology information systems.
How is the Varian Treatment (VTx) regulated, and what does this imply for its use in clinical environments?
The VTx is regulated under the FDA’s 510(k) clearance process (K151882) and adheres to the Medical Device Regulation (MDR) framework. This classification implies that it has undergone evaluation to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and performance standards for use in radiology departments and cancer treatment centers as a software-based treatment delivery management tool.
What types of radiation therapy equipment does the Varian Treatment (VTx) integrate with, and how does this affect its compatibility?
The VTx is specifically designed to integrate with external radiation therapy delivery systems, including various linear accelerators. The provided OpenFDA data lists multiple linear accelerator registration numbers, confirming its compatibility with a broad range of these devices. This ensures seamless workflow coordination between the VTx software and existing equipment in clinical settings.
Does the Varian Treatment (VTx) require any special handling or storage conditions?
As a software-based solution, the VTx does not have physical storage requirements like traditional medical devices. However, it must be installed on compatible hardware within a radiology or oncology department, with regular software updates and system maintenance to ensure optimal performance. No sterility or MRI safety requirements are noted for the software itself.
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: Varian Medical Systems - Wikipedia, Varian Medical Systems – Wikipedia, Varian Treatment (VTx) (K151882) — FDA 510 (k) | Innolitics, Varian Treatment (VTx) 510 (k) K151882 - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K151882 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K151882 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026