AVIEW Modeler— 510(k) K192040

Name: FDA 510(k) clearance K192040
Creator: U.S. Food and Drug Administration
Published: 2019-12-20

Substantially Equivalent

Coreline Soft Co., Ltd.

FDA 510(k) clearance K192040 for AVIEW Modeler, Substantially Equivalent on 2019-12-20. Applicant: Coreline Soft Co., Ltd.. Device class: 2.

Clearance details

Applicant: Coreline Soft Co., Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2019-07-31
Decision date: 2019-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Coreline Soft Co., Ltd.

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K251203 — AVIEW Lung Nodule CAD2025-12-03
K243689 — AVIEW2025-03-19
K243696 — AVIEW CAC2025-02-14
K233211 — AVIEW CAC2024-03-29
K221592 — AVIEW Lung Nodule CAD2023-02-24

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.