Data / Medical devices / South Korea / Coreline Soft Co., Ltd.

Coreline Soft Co., Ltd.: FDA-registered device maker in Seoul, South Korea, 12 510(k) clearances

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

Coreline Soft Co., Ltd. is registered with the FDA (registration 3015169361) in Seoul, South Korea. It lists 5 device types. The FDA files 12 510(k) clearances under its listings, the newest dated December 3, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015169361
Address: 12, Donggyo-ro 19-gil, Mapo-gu, Seoul, South Korea, 04001
Owner or operator: Coreline Soft Co., Ltd. (10059497)
Roles: Complaint file establishment, Manufacturer
First device listed: January 29, 2019
Registered through: 2026
Brand names listed: AVIEW, AVIEW 2, AVIEW CAC, AVIEW LCS, AVIEW Lung Nodule CAD, AVIEW Modeler, AVIEW RT ACS, AView LCS

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lung Computed Tomography System, Computer-Aided Detection	OEB	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Radiological Image Processing Software For Radiation Therapy	QKB	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Complaint file establishment, 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
December 3, 2025	K251203	AVIEW Lung Nodule CAD	OEB	Substantially Equivalent	Coreline Soft Co., Ltd.	accessdata.fda.gov
March 19, 2025	K243689	AVIEW	QIH	Substantially Equivalent	Coreline Soft Co., Ltd.	accessdata.fda.gov
February 14, 2025	K243696	AVIEW CAC	QIH	Substantially Equivalent	Coreline Soft Co., Ltd.	accessdata.fda.gov
March 29, 2024	K233211	AVIEW CAC	QIH	Substantially Equivalent	Coreline Soft Co., Ltd.	accessdata.fda.gov
February 24, 2023	K221592	AVIEW Lung Nodule CAD	OEB	Substantially Equivalent	Coreline Soft Co., Ltd.	accessdata.fda.gov
December 23, 2022	K214036	AVIEW	QIH	Substantially Equivalent	Coreline Soft Co., Ltd.	accessdata.fda.gov
November 10, 2022	K220408	AVIEW RT ACS	QKB	Substantially Equivalent	Coreline Soft Co., Ltd.	accessdata.fda.gov
October 16, 2020	K201710	A View LCS	LLZ	Substantially Equivalent	Coreline Soft Co., Ltd.	accessdata.fda.gov
August 26, 2020	K200714	AVIEW	LLZ	Substantially Equivalent	Coreline Soft Co., Ltd.	accessdata.fda.gov
May 5, 2020	K193220	AVIEW LCS	LLZ	Substantially Equivalent	Coreline Soft Co., Ltd.	accessdata.fda.gov
December 20, 2019	K192040	AVIEW Modeler	LLZ	Substantially Equivalent	Coreline Soft Co., Ltd.	accessdata.fda.gov
October 31, 2018	K171199	AVIEW	LLZ	Substantially Equivalent	Coreline Soft Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 3, 2025. 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.