Cleared Traditional

AVIEW Lung Nodule CAD

K251203 · Coreline Soft Co., Ltd. · Radiology

Dec 2025

Decision

229d

Days

Class 2

Risk

About This 510(k) Submission

K251203 is an FDA 510(k) clearance for the AVIEW Lung Nodule CAD, a Lung Computed Tomography System, Computer-aided Detection (Class II — Special Controls, product code OEB), submitted by Coreline Soft Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on December 3, 2025, 229 days after receiving the submission on April 18, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K251203 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2025
Decision Date	December 03, 2025
Days to Decision	229 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OEB — Lung Computed Tomography System, Computer-aided Detection
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2050
Definition	To Assist Radiologists In The Review Of Multi-slice Computed Tomography (msct) Exams Of The Chest And Highlight Potential Nodules That The Radiologist Should Review. A Computer Aided Diagnosis, Lung Computed Tomography System Is A Class 3 Device Under Product Code Nrr.