Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013501671

FEI Number

3013501671

Entity Name

LG ELECTRONICS INC.

City/State/Country

Gumi-si Gyeongbuk, KR

Establishment Address

168, Suchul-daero, Gyeongsangbuk-do, Gumi-si Gyeongbuk 39368, KR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

LG Electronics Inc Monitor Division. (Owner Number: 10053135)

Owner / Operator Contact Address

222, LG-ro, Jinwi-myeon, Pyeongtaek-si, KR-41 17709, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220559

PMA Number

N/A

All Registered Proprietary Names

21HQ613D 32HQ713D 21HQ513D 31HN713D 32HL512D 32HQ713D ASHK100G 21HQ513D 21HK512D 17HK700G-W 17HK700G-WP 17HQ701G-BP 17HQ701G-B 27HJ713S 27HS714S 32HQ713D 32HL512D 31HN713D 31HN713D 32HST70S 27HJ710S, 27HK510S, 27HQ710S, 32HL710S, 32HL714S, 55MH5K, AR-3250-3212 MLW-2750UHD 19HK312C, 27HJ712C, 27HJ713C, 27HS713C 24CK560N 24CN670NK, 24CN670WK, 24CN670IK 24CR670NK, 24CR670WK, 24CR670IK, 24CR671NK, 24CR671WK, 24CR671IK, 24CR670W 14HQ901G-B 14HQ901G-BP 14HQ701G-BP 14HQ701G-B 24HR513C ASHK100G 10HQ701G-B 10HQ701G-BP ASHK100G 17HQ901G-B 17HQ901G-BP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-02-20
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2023-03-08
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-06-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-06-19
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-06-19
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2019-12-05
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-07-31
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-07-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-06-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-02-10
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-06-19
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2020-10-14
FWB	Camera, Television, Surgical, Without Audio	General, Plastic Surgery	Class 1	878.4160	2016-11-03
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-02-24
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-07-25
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-01-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-07-24
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-07-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-01-06
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-07-25

Official Correspondent

No official correspondent registered.

US Agent Details

Heejae Cho Email: heejae.cho@lge.com Phone: (201) 4722623

Related Public Records

Same Entity

LG Electronics Inc Monitor Division.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004434200	LG Electronics Nanjing New Technology Co., Ltd.	Nanjing Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163335	Eizo Corporation	6MP Color LCD Monitor, RadiForce RX660, RX660-AR	2016-12-15
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

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)

Similar Registrations

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3013084615	D&T INC.	Yuseong-gu Daejeon, KR
3024897454	TAURUS MEDICAL SOLUTIONS LTD	Cannock Staffordshire, GB
3000237660	EIZO CORPORATION	HAKUSAN Ishikawa, JP
3004082357	WIDE CORPORATION	Hwaseong-si Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013501671. Last updated year: 2026. Please use registration number 3013501671 when referencing this establishment in official correspondence.