Data / Medical devices / South Korea / Heuron Co., Ltd.

Heuron Co., Ltd.: FDA-registered device maker in Seoul, South Korea, 5 510(k) clearances

Name: Heuron Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Heuron Co., Ltd. is registered with the FDA (registration 3016727312) in Seoul, South Korea. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 15, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016727312
Address: 10F, C, 150, Yeongdeungpo-ro, Yeongdeungpo-gu, Seoul, South Korea, 07292
Owner or operator: Heuron Co., Ltd. (10080283)
Roles: Manufacturer
First device listed: January 24, 2021
Registered through: 2026
Brand names listed: Heuron ICH, Veuron-Brain-mN1, Veuron-Brain-pAb, Veuron-Brain-pAb2

Devices it lists

Device	Product code	Class	Role	Source
Radiological Computer-Assisted Triage And Notification Software	QAS	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 15, 2024	K233247	Heuron ICH	QAS	Substantially Equivalent	Heuron Co., Ltd.	accessdata.fda.gov
October 13, 2023	K231642	Veuron-Brain-pAb3	LLZ	Substantially Equivalent	Heuron Co., Ltd.	accessdata.fda.gov
July 12, 2022	K203279	Veuron-Brain-mN1	LNH	Substantially Equivalent	Heuron Co., Ltd.	accessdata.fda.gov
February 4, 2022	K213801	Veuron-Brain-pAb2	LLZ	Substantially Equivalent	Heuron Co., Ltd.	accessdata.fda.gov
January 15, 2021	K203142	Veuron-Brain-pAb	LLZ	Substantially Equivalent	Heuron Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 15, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.