Varian Ximatron C-Series Radiation Therapy Simulator With Version 4.2 Software
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K964138 FDA 510(k)
- FDA Product Code
- KPQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5840 FDA 510(k)
- Regulation Number
- 892.5840 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A radiation therapy simulator system used for treatment planning in radiotherapy. It is a device that includes signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
Supplied as a non-sterile, reusable system for use in clinical radiotherapy settings. It is authorized under FDA 510(k) clearance K964138 and classified as a Class II medical device with product code KPQ.
Frequently asked questions
What is the Varian Ximatron C-Series Radiation Therapy Simulator used for?
It is used for treatment planning in radiotherapy, providing signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, and related accessories to assist in preparing radiation treatment plans.
Is the Varian Ximatron C-Series simulator sterile or non-sterile, and is it intended for single-use or reuse?
The system is supplied as non-sterile and is designed for reuse in clinical radiotherapy settings, meaning it can be cleaned and used multiple times following appropriate facility protocols.
What components are included in the Varian Ximatron C-Series Radiation Therapy Simulator system?
The system includes signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories necessary for radiotherapy treatment planning.
What regulatory pathway was used for the Varian Ximatron C-Series simulator, and what is its classification?
It received FDA 510(k) clearance under K964138 and is classified as a Class II medical device with product code KPQ, indicating substantial equivalence 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: Varian Ximatron C-series Radiation Therapy Simulator With Version 4.2 ..., Varian Medical Systems - Wikipedia, PDF K964138 Varian Ximatron C-series Radiation Therapy Simulator With ..., Varian Medical Systems – Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K964138 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (1)
- FDA 510(k) K964138 24 fields · synced Oct 6, 2026