Medical Device Manufacturer · KR , Seoul

Coreline Soft Co., Ltd. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2018

Recent clearances: AVIEW Lung Nodule CAD, AVIEW, AVIEW CAC

Total

Cleared

Denied

Coreline Soft Co., Ltd. has 12 FDA 510(k) cleared radiology devices. Based in Seoul, KR.

Latest FDA clearance: Dec 2025. Active since 2018.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by LK Consulting Group USA, Inc. as regulatory consultant.

Coreline Soft Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Coreline Soft Co., Ltd.

12 devices

1-12 of 12

Cleared Dec 03, 2025

AVIEW Lung Nodule CAD

AVIEW Lung Nodule CAD

Coreline Soft Co., Ltd. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Coreline Soft Co., Ltd.

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