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Patxfer

by Brainlab AG

510(k) K021583

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK021583 Date12 Aug 2002ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LLZ
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

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