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AlignRT Plus (8.0)

by Vision RT Ltd.

510(k) K253012

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253012↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK253012 Date18 Mar 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253012 decided 18 Mar 2026 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
IYE
FDA applicant
Vision Rt, Ltd.
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 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.

Devices cleared under K253012

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K253012
UDI-DISize and differences
AlignRT Plus 8.1
Vision RT Limited
8.105056190501211 —On the market

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

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