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The Tracker / October 2026 / K260391

510(k) cleared

AVIEW Aorta Metrics

Coreline Soft Co., Ltd. · Oct 16, 2026 · K260391

FDA cleared the AVIEW Aorta Metrics from Coreline Soft Co., Ltd. on Oct 16, 2026 under K260391, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 6, 2026. The decision came 252 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Coreline Soft Co., Ltd. has one other decision in the tracker over the last 12 months: K251203 (AVIEW Lung Nodule CAD).

Questions & Answers

What did FDA clear under K260391?

K260391 is the FDA 510(k) for AVIEW Aorta Metrics, submitted by Coreline Soft Co., Ltd.. FDA's decision date was Oct 16, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the AVIEW Aorta Metrics?

Coreline Soft Co., Ltd., based in Seoul, is the applicant of record for K260391.

How long did the K260391 review take?

FDA received the submission on Feb 6, 2026 and issued its decision on Oct 16, 2026, 252 days later.

← All decisions in October 2026

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