Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016727312

FEI Number

3016727312

Entity Name

HEURON CO., LTD.

City/State/Country

Seoul, KR

Establishment Address

10F, C, 150, Yeongdeungpo-ro, Yeongdeungpo-gu, Seoul 07292, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Heuron Co., Ltd. (Owner Number: 10080283)

Owner / Operator Contact Address

10F, C, 150, Yeongdeungpo-ro, Yeongdeungpo-gu, Seoul, KR-11 07292, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Heuron ICH Veuron-Brain-mN1 Veuron-Brain-pAb2 Veuron-Brain-pAb

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	2024-06-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-07-13
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-07-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-10-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-02-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-01-24

Official Correspondent

Yuri Choi

US Agent Details

Jung Ryun Ahn Email: kmc.usa@kmcerti.com Phone: (646) 3576058

Related Public Records

Same Entity

Heuron 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
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
3023702863	Harrison-AI Medical Pty Ltd	Sydney New South Wales, AU
3004977335	Siemens Healthineers AG	FORCHHEIM Bavaria, DE
3017840913	QURE.AI TECHNOLOGIES PRIVATE LIMITED	Mumbai Maharashtra, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016727312. Last updated year: 2026. Please use registration number 3016727312 when referencing this establishment in official correspondence.