Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038177848

FEI Number

3038177848

Entity Name

JLK, INC.

City/State/Country

Gangnam Seoul, KR

Establishment Address

Teheranro33-Gil 5/11f, Gangnam Seoul 06141, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

JLK Inc (Owner Number: 10092928)

Owner / Operator Contact Address

11F, 5, Teheran-ro 33-gil, Gangnam-gu, KR-11 06141, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242556

PMA Number

N/A

All Registered Proprietary Names

JLK-ICH JLK-LVO JLK-PWI JLK-SDH JLK-CTP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2025-03-07
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2025-03-07
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-03-07
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2025-03-12
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-03-07

Official Correspondent

No official correspondent registered.

US Agent Details

Heesun Kim Business: JLK USA, Inc. Email: heesunkim@jlkgroup.com Phone: (530) 5749393

Related Public Records

Same Entity

JLK Inc

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
K220709	Aidoc Medical , Ltd.	BriefCase	2022-10-07
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

Registration Number	Establishment Name	Location
3021915828	NICo-Lab B.V.	Amsterdam Noord-Holland, NL
3017604664	AVICENNA.AI	La Ciotat Bouches-du-Rhone, FR
3016727312	HEURON CO., LTD.	Seoul, KR
3023702863	Harrison-AI Medical Pty Ltd	Sydney New South Wales, AU
3004977335	Siemens Healthineers AG	FORCHHEIM Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038177848. Last updated year: 2026. Please use registration number 3038177848 when referencing this establishment in official correspondence.