InferRead Lung CT.AI— 510(k) K240554

Name: FDA 510(k) clearance K240554
Creator: U.S. Food and Drug Administration
Published: 2025-05-16

Substantially Equivalent

Infervision Medical Technology Co., Ltd.

FDA 510(k) clearance K240554 for InferRead Lung CT.AI, Substantially Equivalent on 2025-05-16. Applicant: Infervision Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Infervision Medical Technology Co., Ltd.
Product code: Code OEB
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-02-28
Decision date: 2025-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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