CORELINE SOFT CO., LTD.

FDA Device Registration & Listing · Seoul, KR · Registration 3015169361

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015169361
FEI Number
3015169361
Entity Name
CORELINE SOFT CO., LTD.
City/State/Country
Seoul, KR
Establishment Address
12, Donggyo-ro 19-gil, Mapo-gu, Seoul 04001, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Coreline Soft Co., Ltd. (Owner Number: 10059497)
Owner / Operator Contact Address
12, Donggyo-ro 19-gil,, Mapo-gu, Seoul, KR-NOTA 04001, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200714
PMA Number
N/A

All Registered Proprietary Names

AVIEW AVIEW LCS AVIEW Modeler AVIEW Lung Nodule CAD AVIEW CAC AView LCS AVIEW AVIEW AVIEW CAC AVIEW 2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2019-01-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-05-05
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-05-05
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2019-12-22
OEB Lung Computed Tomography System, Computer-Aided Detection Radiology Class 2 892.2050 2023-02-27
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-02-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-04-21
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-04-21
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-11-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-11-18
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-12-27
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2022-12-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-03-23
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-03-23
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-02-18
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-02-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-11-18
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-11-18

Official Correspondent

Hye Yi Park

US Agent Details

David Hyun Jun Paek Email: dpaek.rennes@gmail.com Phone: (818) 9030660

Related Public Records

Same Entity

Coreline Soft 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
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
K122260 Aycan Digitalsysteme GmbH AYCAN MOBILE 2012-09-12

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)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015169361. Last updated year: 2026. Please use registration number 3015169361 when referencing this establishment in official correspondence.
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