AVIEW CAC— 510(k) K243696

Substantially Equivalent

Coreline Soft Co., Ltd.

FDA 510(k) clearance K243696 for AVIEW CAC, Substantially Equivalent on 2025-02-14. Applicant: Coreline Soft Co., Ltd.. Device class: 2.

Clearance details

Applicant: Coreline Soft Co., Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-11-29
Decision date: 2025-02-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Coreline Soft Co., Ltd.

K251203 — AVIEW Lung Nodule CAD2025-12-03
K243689 — AVIEW2025-03-19
K233211 — AVIEW CAC2024-03-29
K221592 — AVIEW Lung Nodule CAD2023-02-24
K214036 — AVIEW2022-12-23

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