AVIEW RT ACS— 510(k) K220408

Substantially Equivalent

Coreline Soft Co., Ltd.

FDA 510(k) clearance K220408 for AVIEW RT ACS, Substantially Equivalent on 2022-11-10. Applicant: Coreline Soft Co., Ltd.. Device class: 2.

Clearance details

Applicant: Coreline Soft Co., Ltd.
Product code: Code QKB
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2022-02-14
Decision date: 2022-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QKB

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K260528 — OncoStudio2026-07-02
K252190 — DeepBT Detector-Plus2026-04-10
K252548 — AI-Rad Companion Organs RT2026-04-10

More clearances from Coreline Soft Co., Ltd.

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

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