AVIEW Lung Nodule CAD— 510(k) K221592

Substantially Equivalent

Coreline Soft Co., Ltd.

FDA 510(k) clearance K221592 for AVIEW Lung Nodule CAD, Substantially Equivalent on 2023-02-24. 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: 2022-06-02
Decision date: 2023-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Coreline Soft Co., Ltd.

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