InferRead CT Stroke.AI— 510(k) K211179

Name: FDA 510(k) clearance K211179
Creator: U.S. Food and Drug Administration
Published: 2021-08-12

Substantially Equivalent

Infervision Medical Technology Co., Ltd.

FDA 510(k) clearance K211179 for InferRead CT Stroke.AI, Substantially Equivalent on 2021-08-12. Applicant: Infervision Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Infervision Medical Technology Co., Ltd.
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2021-04-20
Decision date: 2021-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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