AVIEW Aorta Metrics— 510(k) K260391

Name: FDA 510(k) clearance K260391
Creator: U.S. Food and Drug Administration
Published: 2026-10-16

Substantially Equivalent

Coreline Soft Co., Ltd.

FDA 510(k) clearance K260391 for AVIEW Aorta Metrics, Substantially Equivalent on 2026-10-16. Applicant: Coreline Soft Co., Ltd.. Device class: 2.

Clearance details

Applicant: Coreline Soft Co., Ltd.
Product code: Product code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2026-02-06
Decision date: 2026-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code JAK

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K261225 — CAS-One IR2026-09-29
K261125 — BodyTom 64 (NL4100); OmniTom Elite (NL5000)2026-09-22
K261229 — SCENARIA View Phase 6.02026-09-18
K253836 — FCT iStream Phase 22026-09-04
K253450 — BodyTom Elite (NL4000)2026-07-28

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 JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.