Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181404 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 High Energy Linear Accelerator is a permanently installed device that generates a radiotherapy treatment beam through a linear accelerator assembly consisting of an electron gun, waveguide, and collimator. The Varian Multileaf Collimator (MLC) is an accessory X-ray collimator designed to be mounted on a Varian radiotherapy linear accelerator.
The device is supplied by Varian Medical Systems, Inc. and is authorized under FDA 510K clearance with product code IYE. The device is substantially equivalent to predicate devices K162476, K132705, and K133240, with the same basic operation and technological characteristics. Operational differences are described in the Instructions for Use and accompanying user documentation.
Frequently asked questions
What is the Varian High Energy Linear Accelerator with Multileaf Collimator used for?
The Varian High Energy Linear Accelerator is a permanently installed device that generates a radiotherapy treatment beam through a linear accelerator assembly. The Multileaf Collimator is an accessory X-ray collimator designed to be mounted on the Varian radiotherapy linear accelerator to shape the treatment beam.
How is the Varian High Energy Linear Accelerator with Multileaf Collimator supplied?
The device is supplied by Varian Medical Systems, Inc. as a complete system including the linear accelerator assembly and the Multileaf Collimator accessory. It comes with Instructions for Use and accompanying user documentation that describe operational differences from predicate devices.
What is the regulatory status of the Varian High Energy Linear Accelerator with Multileaf Collimator?
The device is authorized under FDA 510K clearance with product code IYE. It is substantially equivalent to predicate devices K162476, K132705, and K133240, with the same basic operation and technological characteristics. The clearance was received on 2018-05-29 and decided on 2018-06-28.
Is the Varian High Energy Linear Accelerator with Multileaf Collimator reusable or single-use?
The device is permanently installed and designed for repeated use in clinical settings. It is not a single-use device and is intended to be maintained according to the manufacturer's specifications for long-term operation in radiotherapy departments.
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 High Energy Linear Accelerator, UNIQUE, Varian Multileaf ..., Varian Medical Systems - Wikipedia, PDF Varian Medical Systems, Inc. +VOF Peter J. Coronado Director ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181404 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (1)
- FDA 510(k) K181404 24 fields · synced Oct 6, 2026