Medical Device Manufacturer · KR , Seoul

Coreline Soft Co., Ltd.

12 submissions · 12 cleared · Since 2018
12
Total
12
Cleared
0
Denied

Coreline Soft Co., Ltd. — FDA 510(k) Submissions

Coreline Soft Co., Ltd. has submitted 12 FDA 510(k) premarket notifications since 2018, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Image Processing, Radiological, Automated Radiological Image Processing Software, Lung Computed Tomography System, Computer-aided Detection, Radiological Image Processing Software For Radiation Therapy . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
AVIEW Lung Nodule CAD
K251203 · OEB Lung Computed Tomography... · Radiology
Dec 2025 229d
AVIEW
K243689 · QIH Automated Radiological... · Radiology
Mar 2025 110d
AVIEW CAC
K243696 · QIH Automated Radiological... · Radiology
Feb 2025 77d
AVIEW CAC
K233211 · QIH Automated Radiological... · Radiology
Mar 2024 183d
AVIEW Lung Nodule CAD
K221592 · OEB Lung Computed Tomography... · Radiology
Feb 2023 267d
AVIEW
K214036 · QIH Automated Radiological... · Radiology
Dec 2022 365d
AVIEW RT ACS
K220408 · QKB Radiological Image... · Radiology
Nov 2022 269d
A View LCS
K201710 · LLZ System, Image Processing,... · Radiology
Oct 2020 115d
AVIEW
K200714 · LLZ System, Image Processing,... · Radiology
Aug 2020 161d
AVIEW LCS
K193220 · LLZ System, Image Processing,... · Radiology
May 2020 166d
AVIEW Modeler
K192040 · LLZ System, Image Processing,... · Radiology
Dec 2019 142d
AVIEW
K171199 · LLZ System, Image Processing,... · Radiology
Oct 2018 555d
Filters
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