Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007065358

FEI Number

3007065358

Entity Name

DEXCOWIN CO., LTD.

City/State/Country

Seoul, KR

Establishment Address

901-905, 25, Gasan digital 1-ro, Geumcheon-gu, Seoul 08594, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dexcowin Co., Ltd. (Owner Number: 10025963)

Owner / Operator Contact Address

901-905, 25, Gasan digital 1-ro,, Geumcheon-gu, Seoul, KR-11 08594, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K134055

PMA Number

N/A

All Registered Proprietary Names

Cocoon DX-7017 Cocoon DX-7020 CS 2500P Rex 2 COCOON SOLO (DX-7020s) ADX6000 ADX6000s AllMy T Stand Tiggle iRay D3 DX3000 ADX 4000 iRay D4

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2017-12-06
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2014-11-07
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2014-11-07
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2025-11-18
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2017-01-16
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	2015-11-25
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2015-11-25
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2014-11-07
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2014-11-07

Official Correspondent

Seung-Bum Ryu

US Agent Details

Dave Kim Business: Mtech Group LLC Email: davekim@mtechgroupllc.com Phone: (713) 4672607

Related Public Records

Same Entity

Dexcowin 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
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.
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.

Similar Registrations

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2032641	CYBER MEDICAL IMAGING, INC.	Los Angeles, CA, US
3004706313	VATECH CO., LTD.	Hwaseong-si Gyeonggi, KR
3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007065358. Last updated year: 2026. Please use registration number 3007065358 when referencing this establishment in official correspondence.