Data / Medical devices / United Kingdom / Vision RT Limited
Vision RT Limited: FDA-registered device maker in LONDON London, City of, United Kingdom, 10 510(k) clearances
Vision RT Limited is registered with the FDA (registration 3004832819) in LONDON London, City of, United Kingdom. It lists 2 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 18, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004832819
- Address
- Dove House Arcadia Avenue, LONDON London, City of, United Kingdom, N3 2JU
- Owner or operator
- VISION RT LIMITED (9063759)
- Roles
- Complaint file establishment, Foreign private label distributor, Manufacturer, Specification developer
- First device listed
- February 2, 2006
- Registered through
- 2026
- Brand names listed
- ALIGNRT, AlignRT, AlignRT Advance, AlignRT InBore, AlignRT Offline, AlignRT Plus, AlignRT SRS module, AlignRT system and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment, Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 18, 2026 | K253012 | AlignRT Plus (8.0) | IYE | Substantially Equivalent | Vision Rt, Ltd. | accessdata.fda.gov |
| May 19, 2025 | K243301 | MapRT | IYE | Substantially Equivalent | Vision Rt, Ltd. | accessdata.fda.gov |
| March 29, 2024 | K233622 | AlignRT Plus | IYE | Substantially Equivalent | Vision Rt, Ltd. | accessdata.fda.gov |
| June 23, 2023 | K231185 | MapRT | IYE | Substantially Equivalent | Vision Rt, Ltd. | accessdata.fda.gov |
| November 10, 2021 | K212583 | AlignRT Plus | IYE | Substantially Equivalent | Vision Rt, Ltd. | accessdata.fda.gov |
| September 15, 2021 | K212606 | BeamSite | IYE | Substantially Equivalent | Doseoptics, LLC | accessdata.fda.gov |
| March 4, 2021 | K203387 | AlignRT Plus | IYE | Substantially Equivalent | Vision Rt, Ltd. | accessdata.fda.gov |
| January 8, 2013 | K123371 | ALIGNRT PLUS | IYE | Substantially Equivalent | Vision RT Limited | accessdata.fda.gov |
| October 1, 2007 | K072171 | GATECT-RT | IYE | Substantially Equivalent | Vision RT Limited | accessdata.fda.gov |
| January 6, 2006 | K052682 | ALIGNRT | IYE | Substantially Equivalent | Vision RT Limited | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 27, 2025 | 98236 | Class II | Ongoing | The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement. | 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 Notic | accessdata.fda.gov |
| August 24, 2018 | 81089 | Class II | Terminated | Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D befo | RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB | accessdata.fda.gov |
| June 30, 2016 | 74607 | Class II | Terminated | AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radia | 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 | accessdata.fda.gov |
Compare with other makers
Updated March 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.