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Patxfer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K021583

by Brainlab AG

Identifiers

510(k) Number
K021583 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The PatXfer RT is a medical imaging system designed for the acceptance, transfer, display, storage, and digital processing of radiotherapy (RT) images and data. It adheres to the DICOM RT standard and supports BrainLab’s proprietary data formats, enabling integration with radiotherapy workflows. This device facilitates the handling of medical images and objects required for precise treatment planning and delivery in radiation therapy.

PatXfer RT is supplied as a software-based solution for use in radiology departments, interfacing with existing imaging and radiotherapy systems. It is intended for single-use or multi-user environments, though sterility is not applicable as it is a non-sterile software application. The device operates in MRI-unsafe environments and requires appropriate IT infrastructure for installation. Authorized under FDA 510(k) clearance (K021583), it is classified as a Class II medical device.

Frequently asked questions

What types of medical images and data does the PatXfer RT system support for radiotherapy workflows?

The PatXfer RT system is designed to handle radiotherapy (RT) images and data following the DICOM RT standard, ensuring compatibility with radiotherapy workflows. It also supports BrainLab’s proprietary data formats, allowing seamless integration with existing imaging and radiotherapy systems for precise treatment planning and delivery.

Is the PatXfer RT system intended for use in MRI environments, and what infrastructure requirements does it have?

The PatXfer RT system is explicitly designed for MRI-unsafe environments, meaning it cannot be used inside or near MRI scanners. Since it is a software-based solution, it requires appropriate IT infrastructure for installation, including compatible hardware and network connectivity to function within radiology departments.

How is the PatXfer RT system supplied, and is it reusable or single-use?

The PatXfer RT is supplied as a software-based solution, meaning it is not a physical device with consumable components. It is intended for use in both single-user and multi-user environments, though its reusability depends on the IT infrastructure and licensing agreements rather than physical limitations. Sterility is not applicable, as it is a non-sterile software application.

What regulatory pathway was followed for the FDA clearance of the PatXfer RT system, and what class does it belong to?

The PatXfer RT system received FDA clearance through a traditional 510(k) pathway, specifically under clearance number K021583. It is classified as a Class II medical device, which indicates a moderate level of regulatory oversight due to its role in handling critical radiotherapy data and imaging.

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: PATXFER RT by BRAINLAB, AG | FDA 510 (k) Summary, Brainlab Patxfer | allmed.wiki, Brainlab Patxfer RT - allmed.wiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Brainlab AG

Sources (1)

  • FDA 510(k) K021583 24 fields · synced Sep 20, 2026