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Trilogy MX

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092871

by Varian Medical Systems, Inc.

Identifiers

510(k) Number
K092871 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 MX is a linear accelerator medical device used for radiation therapy in radiology applications. It is designed to deliver precise radiation treatment for cancer patients.

The Trilogy MX is manufactured by Varian Medical Systems, Inc. and is a Class II device with FDA 510(k) clearance. It is supplied in various sizes and models as specified by the manufacturer, with storage requirements as directed by the company.

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: TRILOGY MX (K092871) — FDA 510(k) | Innolitics, TRILOGY MX 510 (k) K092871 - FDA.report, Varian Trilogy MX - allmed.wiki, PDF K092871 - Trilogy Mx, Varian Trilogy — XRAYN

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Varian Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K092871 24 fields · synced Oct 6, 2026