Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002707445

FEI Number

3002707445

Entity Name

SOYEE PRODUCT, INC.

City/State/Country

KANGNAM-KU, SEOUL Gyeonggi, KR

Establishment Address

1909-2 KWTC 159-1 SAMSUNG DONG, KANGNAM-KU, SEOUL Gyeonggi --, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SOYEE PRODUCT, INC. (Owner Number: 9072175)

Owner / Operator Contact Address

1909-2 KWTC 159-1 SAMSUNG DONG, --, KANGNAM-KU, SEOUL, KR-NOTA 135090, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

System, x-ray, mobile Grid, radiographic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2007-08-07
IXJ	Grid, Radiographic	Radiology	Class 1	892.1910	2005-04-12

Official Correspondent

Soon Han Kwon

US Agent Details

Sojung Kwon Email: wetdocument@gmail.com Phone: (310) 4658135

Related Public Records

Same Entity

SOYEE PRODUCT, INC.

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

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.

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3007734888	WIPRO GE HEALTHCARE PRIVATE Ltd.	BANGALORE Karnataka, IN
2126677	GE MEDICAL SYSTEMS, LLC	Waukesha, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002707445. Last updated year: 2026. Please use registration number 3002707445 when referencing this establishment in official correspondence.