InferRead Lung CT.AI— 510(k) K192880

Name: FDA 510(k) clearance K192880
Creator: U.S. Food and Drug Administration
Published: 2020-07-02

Substantially Equivalent

Beijing Infervision Technology Co., Ltd.

FDA 510(k) clearance K192880 for InferRead Lung CT.AI, Substantially Equivalent on 2020-07-02. Applicant: Beijing Infervision Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Beijing Infervision Technology Co., Ltd.
Product code: Code OEB
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2019-10-09
Decision date: 2020-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code OEB

view all

K254075 — Synapse Lung Nodule AI2026-05-27
K251203 — AVIEW Lung Nodule CAD2025-12-03
K240554 — InferRead Lung CT.AI2025-05-16
K242919 — V5med Lung AI2025-03-27
K231157 — syngo.CT Lung CAD (Version VD30)2023-07-19

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