Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004832819

FEI Number

3004832819

Entity Name

VISION RT LIMITED

City/State/Country

LONDON London, City of, GB

Establishment Address

Dove House, Arcadia Avenue, LONDON London, City of N3 2JU, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VISION RT LIMITED (Owner Number: 9063759)

Owner / Operator Contact Address

Dove House, Arcadia Avenue, LONDON, GB-LND N3 2JU, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231185

PMA Number

N/A

All Registered Proprietary Names

MapRT GateRT GateCT GateCT-RT GateRT system AlignRT system OSMS AlignRT Plus AlignRT AlignRT SRS module GateCT system AlignRT Advance AlignRT Plus Touchless4D DoseRT SimRT AlignRT InBore AlignRT AlignRT Offline DoseRT BeamSite AlignRT Plus AlignRT InBore OSMS AlignRT AlignRT Offline Touchless4D AlignRT Advance SimRT MapRT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2025-12-09
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2013-12-18
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2013-01-31
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-04-02
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-10-29
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2021-11-24
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2023-06-26

Official Correspondent

Amy Mansfield

US Agent Details

Ben Waghorn Business: Vision RT Email: bwaghorn@visionrt.com Phone: (770) 8230790

Related Public Records

Same Entity

VISION RT LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014404697	Demant Technology Centre Sp. z o.o.	Warsaw Mazowieckie, PL
3014428919	Vision RT Ltd	Basingstoke Hampshire, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03
K003779	Arplay Medical S.A.	IMMOBILIZATION SYSTEM FOR ENT	2001-07-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

Similar Registrations

Registration Number	Establishment Name	Location
3014113695	JIANGSU RAYER MEDICAL TECHNOLOGY CO., LTD.	Wuxi Jiangsu, CN
1722661	RADIOLOGICAL IMAGING TECHNOLOGY, INC.	Co Spgs, CO, US
3030077501	CHABNER XRT, LLC	Port Chester, NY, US
3007791541	Varian Medical Systems China Co., Ltd.	Beijing, CN
1932738	MEDTEC LLC	Orange City, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004832819. Last updated year: 2026. Please use registration number 3004832819 when referencing this establishment in official correspondence.