# AlignRT Plus (8.0)

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/alignrt-plus-8-0-iye>
- Manufacturer: [Vision RT Ltd.](https://devicerts.com/manufacturers/vision-rt-ltd) (United Kingdom)
- Device class: Class II (US FDA)
- FDA product code: IYE

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The AlignRT Plus (8.0) is a linear accelerator system designed for precise radiation therapy delivery in oncology. It integrates advanced imaging and real-time tracking technologies to ensure accurate targeting of tumours while minimising exposure to surrounding healthy tissue, supporting both external beam radiotherapy and stereotactic ablative radiotherapy (SABR).

This device is supplied as a reusable medical system, intended for use in hospital-based radiation oncology departments. It operates within MRI-safe environments and is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR). The system requires specialised training for operation and maintenance, with components subject to routine calibration and servicing as per manufacturer guidelines. Authorisations include FDA\_510K and MDR compliance, ensuring adherence to stringent safety and performance standards.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K253012 · decision 2026-03-18 · decision SESE · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K253012 [FDA 510(k)]
- FDA product code: IYE [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.5050 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: AlignRT Plus (8.0), Vision RT Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/alignrt-plus-8-0-iye (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/alignrt-plus-8-0-iye.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/alignrt-plus-8-0-iye
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.