Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005172103

FEI Number

3005172103

Entity Name

DRTECH Corporation

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

Suite No.1, 2 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero 541beon-gil, JUNGWON-GU, Seongnam-si Gyeonggi 13216, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DRTECH CORPORATION (Owner Number: 9073399)

Owner / Operator Contact Address

Suite No.2, 3 Floor, 29, Dunchon-daero541beon-gil, Jungwon-gu, Seongnam-si, KR-41 13216, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152172

PMA Number

N/A

All Registered Proprietary Names

RSM 1824C with RConsole1 NexGen 900 Series; NexGen 940 Series; NexGen 950 Series; NexGen 960 Series EXSYS DEXi (EXSYS DEXi-A401S-FRM) EXSYS DEXi (EXSYS DEXi-A402P-FRM) EXSYS DEXi (EXSYS DEXi-A503T-FRM) EXSYS DEXi (EXSYS DEXi-D401S-FRM) EXSYS DEXi (EXSYS DEXi-D402S-FRM) EXSYS DEXi (EXSYS DEXi-A401P-FRM) EXSYS DEXi (EXSYS DEXi-D401S-FRA) EXSYS DEXi (EXSYS DEXi-D503T-FRA) EXSYS DEXi (EXSYS DEXi-D402S-FRA) EXSYS DEXi (EXSYS DEXi-A402S-FRM) EXSYS DEXi (EXSYS DEXi-D402P-FRM) EXSYS DEXi (EXSYS DEXi-D503T-FRM) EXSYS DEXi (EXSYS DEXi-D401P-FRA) EXSYS DEXi (EXSYS DEXi-D402P-FRA) EXSYS DEXi (EXSYS DEXi-D401P-FRM) EVS 2430GW, EVS 2430W EConsole2 EXPD 3643D EXPD 4343D FLAATZ 560 RMF-2000 EConsole1 EVS 3643W, EVS 3643WG, EVS 3643WP, EVS 4343W, EVS 4343WG, EVS 4343WP EXPD 129P, EXPD 129PG, EXPD 86P, EXPD 86PG LLD 129 Basic LLD 129 Compact LLD 129 with rotation LLD 129 without rotation DBS-57M LLD 129 Samsung LLD 86 Basic EXPD 4343U1 EXPD 3643NU EXPD 4343N1 EXPD 3643N1 EXPD 4343N EXPD 4343NU EXPD 3643N EXPD 3643NP EXPD 4343NP EXPD 3643U1 EVS 3643, EVS 3643G EXPD 3643P, EXPD 4343P XERO ? EVS 4343, EVS 4343G EXPD 4343S Econsole1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-08-03
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2017-08-03
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2025-05-08
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2024-11-07
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2017-08-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-09-26
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2024-11-05
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2011-12-05
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2023-06-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-10-26
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-11-25
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-11-24
IXY	Holder, Radiographic Cassette, Wall-Mounted	Radiology	Class 1	892.1880	2022-11-21
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2025-04-01
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2016-12-23
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-11-25
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2024-12-01
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2016-12-23
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2024-11-05
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-12-22

Official Correspondent

SEONGHYUN AHN

US Agent Details

Wonjoong Kwon Email: wjkwon@drtech.com Phone: (925) 9989759

Related Public Records

Same Entity

DRTECH 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
3024891354	DRTECH CORPORATION	Seongnam-si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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3036758981	TAEYOUNG SOFT	Gwacheon-si Gyeonggi, KR
3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005172103. Last updated year: 2026. Please use registration number 3005172103 when referencing this establishment in official correspondence.