Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014404697

FEI Number

3014404697

Entity Name

Demant Technology Centre Sp. z o.o.

City/State/Country

Warsaw Mazowieckie, PL

Establishment Address

Q22, Al. Jana Pawla II 22, 9th Floor, Warsaw Mazowieckie 00-133, PL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K123371

PMA Number

N/A

All Registered Proprietary Names

GateRT system AlignRT system OSMS AlignRT Plus AlignRT AlignRT SRS module GateCT system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2013-01-31

Official Correspondent

Amy Mansfield

US Agent Details

Ben Waghorn 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
3004832819	VISION RT LIMITED	LONDON London, City of, GB
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 3014404697. Last updated year: 2026. Please use registration number 3014404697 when referencing this establishment in official correspondence.