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AlignRT Plus

by Vision RT Ltd.

Part of a family of 39 devices: see the family page

Ref Fujitsu M7010X workstation

Active European Union and United States. Also listed in GUDID (US).

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233622↗

+4 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5056190500573VE Basic UDI-DI 05056190500665UDI-DIDate9 Mar 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK233622 Date29 Mar 2024IssuedStatusActive
United StatesGUDID listing GUDID Number05056190500665 UDI-DI Date23 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5056190500573VE registered 9 Mar 2026 Active
  • FDA 510(k) K233622 decided 29 Mar 2024 Active· +4 more in the status table
  • FDA GUDID UDI-DI 05056190500665 listed 23 Sep 2021 Listed

Timeline

7 dated events

  1. Cleared FDA 510(k) K181218
  2. Cleared FDA 510(k) K193431
  3. Cleared FDA 510(k) K203387
  4. Listed FDA GUDID 05056190500665
  5. Cleared FDA 510(k) K212583
  6. Cleared FDA 510(k) K233622
  7. Registered EUDAMED 5056190500573VE

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Radiological video camera patient positioning/tracking system
Model / reference
Fujitsu M7010X workstation EUDAMED
Fujitsu M7010X GUDID
Primary DI / UDI-DI
05056190500665
Basic UDI-DI
5056190500573VE
Direct marketing DI
05056190500665
510(k) Number
FDA product code
IYE
EMDN code
Z11019099 Various radiotherapy and radiosurgery instruments - other
GMDN term
Radiological video camera patient positioning/tracking system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Fujitsu M7010X workstation
GUDID
Fujitsu M7010X
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
GB-MF-000010499
Authorised representative
Oticon A/S DK-AR-000006135

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 is a Computer-Assisted Radiation Therapy (CART) System (Nomenclature Code: Z11019099), designed for real-time image-guided radiation therapy. It integrates with the Fujitsu M7010X workstation to provide precise patient positioning and alignment, enhancing treatment accuracy during external beam radiotherapy sessions. Classified as a Class IIb medical device, it supports adaptive workflows to reduce setup errors and improve dose delivery consistency.

AlignRT Plus is supplied as a non-sterile, non-reusable system intended for use in radiation oncology departments. It operates in conjunction with MRI-safe environments and is compatible with standard radiation therapy infrastructure. The device requires proper calibration and maintenance as specified by the manufacturer, adhering to FDA 510K and MDR regulatory standards. Storage and handling follow manufacturer guidelines to ensure operational integrity and compliance with medical device regulations.

Similar devices in this category

Other devices filed under VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER.

Other devices from Vision RT Ltd.

See all devices from Vision RT Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)