Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005246977

FEI Number

3005246977

Entity Name

POSKOM CO., LTD

City/State/Country

Goyang-si Gyeonggi, KR

Establishment Address

POSKOM Tower, 227, Sowon-ro, Deogyang-gu, Goyang-si Gyeonggi 10534, KR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

POSKOM CO., LTD (Owner Number: 9053091)

Owner / Operator Contact Address

POSKOM Tower, 227, Sowon-ro, Deogyang-gu, Goyang-si, KR-41 10534, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250976

PMA Number

N/A

All Registered Proprietary Names

AirRay-mini 80F AirRay-mini 90F AirRay-mini 90A AirRay-mini 80A AirRay-mini AirRay AirRay-20HL AirRay-20HW AirRay-20HLW AirRay-20H Xcam PXP-100CA Airbile-100

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	2026-02-26
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2022-12-28
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2020-03-02
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2012-01-12
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2025-12-23

Official Correspondent

Jeonghyun Seong

US Agent Details

Eugene A Lee Business: PXI MEDICAL Email: jerryhana@poskom.com Phone: (847) 9711999

Related Public Records

Same Entity

POSKOM 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
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18

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-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

Similar Registrations

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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
3011416394	Medical Resale PTY Limited	Caloundra QLD Queensland, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005246977. Last updated year: 2026. Please use registration number 3005246977 when referencing this establishment in official correspondence.