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..

Clearance details

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

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