Skip to content

Vision RT Ltd.

Active in EUDAMED
Also registered as VISION RT LIMITED

United Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000010499

Vision RT Ltd. is a medical device manufacturer based in the United Kingdom, with 55 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class IIb and I; FDA Class II) and 6 FDA recalls as of 13 Nov 2026.

Devices
55
Registrations
EUDAMEDFDA
FDA recalls
61 ongoing

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 54
  • FDA GUDID 46
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • EU Class IIb 41
  • EU Class I 13
  • FDA Class II 1
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN GB-MF-000010499

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment, FDA recalls
Authorised rep.
Oticon A/SDK

What Vision RT Ltd. makes

Vision RT Ltd. manufactures reusable device sterilization and disinfection containers, as well as multi-modality therapeutic radiation phantoms used for testing and calibration in radiation therapy systems. Their products include components for real-time imaging and alignment systems, such as fibre hubs, control boxes, and software platforms for radiation treatment verification. Additional offerings include camera isolation transformers, power supply units, and standalone software tools for radiation therapy planning and monitoring.

The company’s portfolio includes devices classified as Class I, Class II, and Class IIb under EU and US regulations. Their products are listed in the EU’s eudamed registry and have undergone 510(k) clearance via the FDA. The manufacturer is based in the United Kingdom.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue55

Newest first, rows 1-50 of 55

Search and filter all 55 devices
Skip device list

  • AlignRT InBore Accuray Ref 05056190501372

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • AlignRT InBore Accuray Control Box Ref V001127

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • AlignRT InBore Radixact PIA Ref V001094

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • AlignRT InBore Accuray Fibre Hub

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • AlignRT 8.2.x Ref AlignRT InBore 8.2

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • DoseRT camera isolation transformer Ref DoseRT isolation transformer

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Horizon PSU Ref V000733

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Real Time Coach Mk3 Ref 5056190501297

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SafeID Kiosk

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • AlignRT 6.x

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • AlignRT 6.1

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • AlignRT Plus (8.0) Ref K253012

    Active Regimes: CE MDR 510(k) Registry: 510(k) Class:II

  • InBore Fibre Hub Ref InBore Varian Fibre Hub

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • InBore 60mm Calibration Plate Riser

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • DoseRT Phase 1b workstation Ref DoseRT workstation

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • AlignRT InBore

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • SimRT 7.2.x

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • AlignRT InBore Varian PIA Ref V000629

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • SimRT

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • AlignRT 6.2.x

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMEDGUDID Class:IIb

  • Horizon CR Ref Horizon Close-Range Camera

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Mevion Interface Unit Ref V000994

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Horizon Ref Horizon camera

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Varian ProBeam Hold - Switch Box Ref V000906

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • DoseRT camera-computer interface box Ref DoseRT camera interface box

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • AlignRT 7.3.x

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMEDGUDID Class:IIb

  • DoseRT camera Ref 05056190500740

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • InBore System Cabinet

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Calibration Plate Narrow

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • SafeID

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • AlignRT 8.1.x

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • MapRT 1.2.x Clearance Mapping

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • AlignRT Plus Ref Fujitsu M7010X workstation

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIb

  • MapRT

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIb

  • SafeID Ref SafeID 2.3

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • DoseRT reference board

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • IGC MMI Breakout Box Ref V000264

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Patient ID Ref Patient ID Module

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • AlignRT InBore 7.0.x

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Rtc Ref Real Time Coach Mk1

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMEDGUDID Class:I

  • Calibration Plate

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Head Adjuster Ref 05056190500047

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • AlignRT 6.3.x

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • AlignRT InBore 6.4.x

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMEDGUDID Class:IIb

  • HD camera Ref HD Camera Gen 4

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMEDGUDID Class:IIb

  • Real-Time Coach Mk2 Ref 5056190500788

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • AlignRT 7.4.x

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • AlignRT 8.0.x

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:IIb

  • AlignRT Offline

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • AlignRT 5.1

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

Rows 1-50 of 55

Showing 1-50 of 55

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
GB-MF-000010499
EU VAT number
GB778447375
EUDAMED status
Active
EUDAMED registered name
Vision RT Ltd.
EUDAMED abbreviated name
Vision RT
Registered address
Dove House, Arcadia Avenue, N3 2JU, London, United Kingdom (ex Northern Ireland)
Phone
+44 (0)20 8346 4300
PRRC contact
Amy Mansfield(public in EUDAMED)

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 6 recalls initiated by Vision RT Ltd., the earliest on 2014-10-15 and the most recent on 2025-08-27. By recorded status: 1 ongoing and 5 terminated. The reasons filed fall into these groups: labeling or instructions for use and software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 1
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 1
  • 2026 0

4 initiated before 2017

  • 2025

    • 27 Aug 2025 Z-0998-2026 Class II Ongoing Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56). Distribution: U.S. and OUS

  • 2018

    • 24 Aug 2018 Z-0065-2019 Class II Terminated RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB Distribution: Nationwide Foreign: Australia, Austria, Azerbaijan, Belgium, Brunei, Bulgaria, Canada, China, Croatia, Denmark, Finland,…
      Full distribution text Nationwide Foreign: Australia, Austria, Azerbaijan, Belgium, Brunei, Bulgaria, Canada, China, Croatia, Denmark, Finland, Georgia, Germany, India, Israel, Italy, Japan, Korea, Lithuania, Malaysia, Morocco, Norway, Poland, Portugal, Puerto Rico, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.
      Submission number: K123371

  • 2016

    • 30 Jun 2016 Z-2667-2016 Class II Terminated 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. Distribution: Product distributed in US. The foreign countries where the product was distributed are as follows: Canada, Germany,…
      Full distribution text Product distributed in US. The foreign countries where the product was distributed are as follows: Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and United Kingdom. No product was distributed to US government accounts.
      Submission number: K123371
    • 30 Jun 2016 Z-2668-2016 Class II Terminated 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. Distribution: Product distributed in US. The foreign countries where the product was distributed are as follows: Canada, Germany,…
      Full distribution text Product distributed in US. The foreign countries where the product was distributed are as follows: Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and United Kingdom. No product was distributed to US government accounts.
      Submission number: K140528

  • 2014

    • 11 Nov 2014 Z-0934-2015 Class II Terminated Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened. Distribution: Nationwide Distribution Submission number: K052682
    • 15 Oct 2014 Z-0464-2015 Class II Terminated Potential failure of AlignRT to assert interlock. Distribution: Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland. Submission number: K123371

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Vision RT Limited US

Frequently asked questions

How many devices does Vision RT Ltd. have in the registry?

The registry currently lists 55 devices for Vision RT Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Vision RT Ltd.'s devices?

Among its 50 most recently registered devices, Vision RT Ltd. has devices listed in EUDAMED (49 devices), FDA 510(k) (1 device) and FDA GUDID (42 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Vision RT Ltd.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Vision RT Ltd.'s devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Vision RT Ltd.?

FDA recall records list 6 recalls initiated by Vision RT Ltd., the most recent initiated on 27 Aug 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Vision RT Ltd. in the registry?

The most recently registered devices listed for Vision RT Ltd. include AlignRT InBore Accuray, AlignRT InBore Accuray Control Box, AlignRT InBore Radixact PIA and AlignRT InBore Accuray Fibre Hub.

Which FDA establishments are linked to Vision RT Ltd.?

1 FDA establishment is linked to Vision RT Ltd. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.