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TrueBeam, TrueBeam STx, Edge, VitalBeam

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223839

by Varian Medical Systems, Inc.

Identifiers

510(k) Number
K223839 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)

TrueBeam, TrueBeam STx, Edge, and VitalBeam are linear accelerator medical devices used for radiation therapy. These devices are designed to deliver precise radiation treatment for various medical conditions.

The TrueBeam systems are manufactured by Varian Medical Systems, Inc. and are Class 2 devices with product code IYE. They are cleared through the Traditional 510(k) pathway and are intended for use in radiology applications. The devices are supplied in various models and configurations as specified by the manufacturer.

Frequently asked questions

What is the TrueBeam system used for?

The TrueBeam systems are linear accelerator medical devices designed to deliver precise radiation treatment for various medical conditions. They are intended for use in radiology applications.

How are the TrueBeam systems supplied?

TrueBeam systems are manufactured by Varian Medical Systems, Inc. and are supplied in various models and configurations as specified by the manufacturer. They are Class 2 devices with product code IYE.

What is the regulatory status of the TrueBeam systems?

The TrueBeam systems are cleared through the Traditional 510(k) pathway with FDA clearance number K223839. They are classified as Class 2 devices and have been determined to be substantially equivalent.

What models are included in the TrueBeam family?

The TrueBeam family includes multiple models: TrueBeam, TrueBeam STx, Edge, and VitalBeam. Each model offers different configurations and capabilities as specified by Varian Medical Systems.

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. September 12, 2023, K231317 FDA 510(k) - TrueBeam | Varian Medical Systems, Inc., Varian TrueBeam STx — XRAYN, TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) - FDA K232870

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) K223839 24 fields · synced Oct 6, 2026