510(k) clearance

AVIEW Aorta Metrics

FDA 510(k) source

510(k) number

K260391

Applicant

Coreline Soft Co., Ltd.

Decision date

Oct 16, 2026

Date received

Feb 6, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

JAK

Device type

System, X-Ray, Tomography, Computed

Device class

Class II

Regulation

21 CFR 892.1750

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Seoul, KR