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AlignRT Plus GateCT

by Vision RT Limited

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

Ref GateCT

AlignRT Plus GateCT is a device classified as Class IIb in the EU and Class II in the US made by Vision RT Limited, registered in EUDAMED on 9 Mar 2026 (Basic UDI-DI 5056190500573VE), cleared under FDA 510(k) K123371 on 8 Jan 2013 (1 earlier submission) and listed in FDA GUDID since 23 Sep 2021 (UDI-DI 05056190500023), active as of 25 Oct 2026. 6 FDA recalls are linked to it.

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 ongoing

6 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123371↗

+1 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 05056190500023UDI-DIDate9 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056190500023 UDI-DI Date23 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK123371 Date8 Jan 2013IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5056190500573VE registered 9 Mar 2026 Active
  • FDA 510(k) K123371 decided 8 Jan 2013 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05056190500023 listed 23 Sep 2021 Listed

Recalls

6 recalls · FDA

    • Terminated Z-0065-2019 FDA Class II initiated 24 Aug 2018

    RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB

    • Terminated Z-2667-2016 FDA Class II initiated 30 Jun 2016

    Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases.

  • 2 recalls, same reason

    • Terminated Z-2150-2016 FDA Class II initiated 23 Jun 2016
    • Terminated Z-2149-2016 FDA Class II initiated 23 Jun 2016

    Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].

    • Terminated Z-0934-2015 FDA Class II initiated 11 Nov 2014

    Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.

    • Terminated Z-0464-2015 FDA Class II initiated 15 Oct 2014

    Potential failure of AlignRT to assert interlock.

Timeline

10 dated events

  1. Cleared FDA 510(k) K052682
  2. Cleared FDA 510(k) K123371
  3. Recall initiated FDA recalls Z-0464-2015
  4. Recall initiated FDA recalls Z-0934-2015
  5. Recall initiated FDA recalls Z-2150-2016
  6. Recall initiated FDA recalls Z-2149-2016
  7. Recall initiated FDA recalls Z-2667-2016
  8. Recall initiated FDA recalls Z-0065-2019
  9. Listed FDA GUDID 05056190500023
  10. Registered EUDAMED 5056190500573VE

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) · GUDID

Trade name
GateCT EUDAMED
AlignRT Plus GUDID
Generic name
Radiological video camera patient positioning/tracking system
Model / reference
GateCT
Primary DI / UDI-DI
05056190500023
Basic UDI-DI
5056190500573VE
Direct marketing DI
05056190500023
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 · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Radiological video camera patient positioning/tracking system

Cleared under the same submission (K123371)

and 3 more cleared under K123371

Similar devices in this category

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

Other devices from Vision RT Limited

See all devices from Vision RT Limited →

Properties

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