Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617016

FEI Number

3002806900

Entity Name

ELEKTA LIMITED

City/State/Country

CRAWLEY West Sussex, GB

Establishment Address

Cornerstone, London Road, CRAWLEY West Sussex RH10 9BL, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ELEKTA AB (Owner Number: 8030893)

Owner / Operator Contact Address

Hagaplan 4, Stockholm, SE-AB SE11368, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Elekta Unity MR Linac Elekta Synergy, Elekta Infinity, Versa HD, Elekta Harmony/Harmony Pro Clarity System EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elek

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2023-03-02
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-03-02
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2021-07-06
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2023-07-13
KPQ	System, Simulation, Radiation Therapy	Radiology	Class 2	892.5840	2023-07-13
IWB	System, Radiation Therapy, Radionuclide	Radiology	Class 2	892.5750	2023-07-13
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2026-01-26

Official Correspondent

No official correspondent registered.

US Agent Details

Thomas Valentine Business: Elekta Email: Thomas.Valentine@elekta.com Phone: (404) 7972537

Related Public Records

Same Entity

ELEKTA AB

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015232217	ELEKTA SOLUTIONS AB	STOCKHOLM, SE
3032638959	Elekta Inc.	San Jose, CA, US
3009894282	ELEKTA BEIJING MEDICAL SYSTEMS CO., LTD	Beijing, CN

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
K033504	General Electric Co.	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	2003-11-25
K013636	GE Medical Systems	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	2002-01-24

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 9617016. Last updated year: 2026. Please use registration number 9617016 when referencing this establishment in official correspondence.