Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009894282

FEI Number

3009894282

Entity Name

ELEKTA BEIJING MEDICAL SYSTEMS CO., LTD

City/State/Country

Beijing, CN

Establishment Address

No. 21, Chuang Xin Road, Science and Technology Park, Changping District, Beijing 102200, CN

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 Synergy, Elekta Infinity, Versa HD, Elekta Harmony/Harmony Pro 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	2021-07-06
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 Inc. 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
9617016	ELEKTA LIMITED	CRAWLEY West Sussex, GB
3015232217	ELEKTA SOLUTIONS AB	STOCKHOLM, SE
3032638959	Elekta Inc.	San Jose, CA, US

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

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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 3009894282. Last updated year: 2026. Please use registration number 3009894282 when referencing this establishment in official correspondence.