EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System— 510(k) K212624

Substantially Equivalent

Ever Fortune.Ai, Co., Ltd.

FDA 510(k) clearance K212624 for EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System, Substantially Equivalent on 2022-04-04. Applicant: Ever Fortune.Ai, Co., Ltd..

Clearance details

Applicant: Ever Fortune.Ai, Co., Ltd.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2021-08-18
Decision date: 2022-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

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