Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023344919

FEI Number

3023344919

Entity Name

FSK CO., LTD

City/State/Country

Gimpo-si Gyeonggi, KR

Establishment Address

605, Gimpo MasterBizPark, 23, Taejang-ro 795beon-gil, Gimpo-si Gyeonggi 10090, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FSK Co., Ltd (Owner Number: 10085627)

Owner / Operator Contact Address

605, Gimpo MasterBizPark, 23, Taejang-ro 795beon-gil, Gimpo-si, KR-41 10090, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iQFlex M

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	2026-03-23
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2022-07-16

Official Correspondent

JuSeon Youn

US Agent Details

Ron Viola Business: First Source Inc. Email: rviola@fsimed.com Phone: (800) 3495980

Related Public Records

Same Entity

FSK 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

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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3011491794	ECOTRON Co., Ltd.	Seoul, KR
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 3023344919. Last updated year: 2026. Please use registration number 3023344919 when referencing this establishment in official correspondence.