AVIEW Lung Nodule CAD— 510(k) K251203

Substantially Equivalent

Coreline Soft Co., Ltd.

FDA 510(k) clearance K251203 for AVIEW Lung Nodule CAD, Substantially Equivalent on 2025-12-03. Applicant: Coreline Soft Co., Ltd.. Device class: 2.

Clearance details

Applicant: Coreline Soft Co., Ltd.
Product code: Code OEB
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-04-18
Decision date: 2025-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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K221592 — AVIEW Lung Nodule CAD2023-02-24

More clearances from Coreline Soft Co., Ltd.

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