Trilogy Radiotherapy Delivery System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061140 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 Trilogy Radiotherapy Delivery System is a linear accelerator medical device designed for radiation therapy delivery. It enables precise beam sculpting and rapid treatment delivery through advanced technologies such as sliding-window IMRT and RapidArc radiotherapy.
The system is supplied by Varian Medical Systems and is a Class II medical device with FDA 510(k) clearance. It is used for stereotactic treatments that may be intracranial or extracranial, consisting of single-session or multi-session applications. The device includes hardware components such as the Klystron, Digital RF driver, and Millennium MLC.
Frequently asked questions
What is the Trilogy Radiotherapy Delivery System used for?
The Trilogy Radiotherapy Delivery System is a linear accelerator designed for radiation therapy delivery. It is used for stereotactic treatments that may be intracranial or extracranial, consisting of single-session or multi-session applications.
What technologies are included in the Trilogy Radiotherapy Delivery System?
The system includes advanced technologies such as sliding-window IMRT and RapidArc radiotherapy, which enable precise beam sculpting and rapid treatment delivery. Hardware components include the Klystron, Digital RF driver, and Millennium MLC.
What is the regulatory status of the Trilogy Radiotherapy Delivery System?
The Trilogy Radiotherapy Delivery System is a Class II medical device with FDA 510(k) clearance. It has been determined to be substantially equivalent to other devices in this category.
Who manufactures the Trilogy Radiotherapy Delivery System?
The Trilogy Radiotherapy Delivery System is manufactured by Varian Medical Systems, a company based in Palo Alto, California. The device is part of their portfolio of radiotherapy equipment.
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: PDF Varian Medical Systems, inc. VAtx IkfX N, Trilogy Brochure - Varian Oncology - PDF Catalogs - MedicalExpo, TRILOGY RADIOTHERAPY DELIVERY SYSTEM (K033343) - FDA 510 (k), TRILOGY RADIOTHERAPY DELIVERY SYSTEM (K033343) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061140 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems
Sources (1)
- FDA 510(k) K061140 24 fields · synced Sep 22, 2026