510(k) · Radiology

AVIEW Lung Nodule CAD

by Coreline Soft Co.,Ltd

AVIEW Lung Nodule CAD is an AI-enabled medical device from Coreline Soft Co.,Ltd that the U.S. FDA cleared through 510(k) K251203 on December 3, 2025. Its lead review panel is Radiology and its primary product code is OEB (Lung Computed Tomography System, Computer-Aided Detection).

See also FDA-cleared AI radiology devices in 2025, all FDA AI clearances in 2025, top radiology AI devices.

Key facts

Submission numberK251203
Pathway510(k)
Date of final decision
Company (FDA list)Coreline Soft Co.,Ltd
Lead review panelRadiology
Primary product codeOEB — Lung Computed Tomography System, Computer-Aided Detection
Applicant (openFDA)Coreline Soft Co., Ltd.
Applicant locationSeoul, KR
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. AVIEW Lung Nodule CAD went through this pathway (K251203).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code OEB covers 10 devices on the FDA AI list. By decision date, this device is #9 of 10 under that code. Coreline Soft Co.,Ltd has 4 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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