Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029916061

FEI Number

3029916061

Entity Name

DRGEM Corporation (Gimcheon Factory)

City/State/Country

Gimcheon-si Gyeongbuk, KR

Establishment Address

213, Saneopdanji-ro, Eomo-myeon, Gimcheon-si, Gyeongsangbuk-do, Republic of Korea, Gimcheon-si Gyeongbuk 39536, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DRGEM CORPORATION (Owner Number: 9101499)

Owner / Operator Contact Address

7Fl, E-B/D Gwangmyeong Techno-Park, 60 Haan-ro,, Gwangmyeong-si, KR-41 14322, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242015

PMA Number

N/A

All Registered Proprietary Names

GEMPACS DXT-17U DXT-12M DXT-8M DXT-14U DXT-10M DXT-11M DXT-15U DXT-13L DXT-19U DXT-11L RAYMO DIAMOND-5A, DIAMOND-6A, DIAMOND-8A, DS20 DXC-RMH DXC-RML DS30 MXR-35 GXR-68 GXR-82 GXR-C40 GXR-40 GXR-32 GXR-U40 GXR-U32 GXR-52 GXR-C52 GXR-C32 GXR-E32 GXR-E40 GXR-EC40 GXR-EC50 GXR-EC25 GXR-EC32 GXR-E25 GXR-E20 GXR-EC20 TOPAZ-32D, TOPAZ-40D WBS WBS-TA WBS-TM RADMAX DIAMOND 5A, DIAMOND 6A, DIAMOND 8A PROMO GXR-E20S, GXR-E25S, GXR-E32S, GXR-E40S FDR Clinica FGXR-EC20S, FDR Clinica FGXR-EC25S, FDR Clinica FGXR-EC32S, FDR Clinica FGXR-EC40S, FDR Clinica FGXR-EC50S GXR-EC20S, GXR-EC25S, GXR-EC32S, GXR-EC40S, GXR-EC50S FDR Clinica FGXR-E20S, FDR Clinica FGXR-E25S, FDR Clinica FGXR-E32S, FDR Clinica FGXR-E40S GXR-32SD, GXR-40SD, GXR-52SD, GXR-68SD, GXR-82SD, GXR-C32SD, GXR-C40SD, GXR-C52SD, GXR-U32SD, GXR-U40SD FDR clinica FGXR-C32S, FDR clinica FGXR-C40S, FDR clinica FGXR-C52S, FDR clinica FGXR-U32S, FDR clinica FGXR-U40S FDR clinica FGXR-32S, FDR clinica FGXR-40S, FDR clinica FGXR-52S, FDR clinica FGXR-68S, FDR clinica FGXR-82S GXR-32S, GXR-40S, GXR-52S, GXR-68S, GXR-82S, GXR-C32S, GXR-C40S, GXR-C52S, GXR-U32S, GXR-U40S TOPAZ-40D TOPAZ-32D

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2024-05-29
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2026-04-09
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2026-05-18
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2026-05-18
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2019-10-17
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-03-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-03-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-03-16
IZX	Collimator, Manual, Radiographic	Radiology	Class 2	892.1610	2018-07-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-03-04
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2026-03-04
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-03-04
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2007-05-11
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2020-05-19
IXY	Holder, Radiographic Cassette, Wall-Mounted	Radiology	Class 1	892.1880	2009-09-04
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-03-10
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2023-05-18
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2025-08-24
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2025-08-24
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2023-09-20
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2025-02-04
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2025-02-04
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2024-12-17
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2024-12-17

Official Correspondent

No official correspondent registered.

US Agent Details

Alex Lee Business: DRGEM AMERICA INC Email: alex@drgem.co.kr Phone: (469) 6109068

Related Public Records

Same Entity

DRGEM CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006551157	DRGEM CORPORATION	Gwangmyeong-si Gyeongbuk, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02
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
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25

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-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-0002-2009	GE Medical Systems, LLC	2	Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029916061. Last updated year: 2026. Please use registration number 3029916061 when referencing this establishment in official correspondence.