Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011491794

FEI Number

3011491794

Entity Name

ECOTRON Co., Ltd.

City/State/Country

Seoul, KR

Establishment Address

501, 502, 504, 505, 506 Ho, Hanshin IT Tower II, 47,, Digital-ro 9-gil, Geumcheon-Gu, Seoul 08511, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ECOTRON Co., Ltd. (Owner Number: 10049861)

Owner / Operator Contact Address

501, 502, 504, 505, 506 Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, KR-11 08511, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EXS-TA40 EXS-TA10 EXS-TA20 EPX Series Mobile X-ray System EPX-F1600, EPX-F2400, EPX-F2800, EPX-F3200, EPX-F4000, EPX-F5000 EXS-BK10 Fluoroscopic Mobile X-ray System, Anyview-500R Extraoral source x-ray system DT-703, ProX Go SXG Series High Voltage Generator SXG-32R, SXG-40R, SXG-52R, SXG-68R, SXG-80R

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2018-02-13
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2015-08-16
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	Class 1	892.1640	2018-02-13
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2016-10-16
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2016-10-16
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2016-10-16
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2022-06-28
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2016-05-15

Official Correspondent

Jun Yong Oh

US Agent Details

Hali Park Business: ECOTRON AMERICA INC. Email: lsb@ecotron.co.kr Phone: (352) 3633132

Related Public Records

Same Entity

ECOTRON Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02
K863853	Superior Medical Products	EAZY COVERS	1987-03-06
K953974	Medivision Medical Imaging, Ltd.	CAMVISION 1000	1996-09-09
K024012	Ge Oec Medical Systems	OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM	2003-03-20
K970608	Guidant Cardiac and Vascular Surgery	EVT MARKER BOARD	1997-04-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1470-2023	FUJIFILM Healthcare Americas Corporation	2	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024	FUJIFILM Healthcare Americas Corporation	2	The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.

Similar Registrations

Registration Number	Establishment Name	Location
3003768277	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3010949642	GE HEALTHCARE (TIANJIN) COMPANY LIMITED	Tianjin, CN
3013836619	Baxter Medical Systems (Suzhou) Co. Ltd	Taicang City Jiangsu, CN
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
3014680784	Domico Med-Device, LLC	Fenton, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011491794. Last updated year: 2026. Please use registration number 3011491794 when referencing this establishment in official correspondence.