EFAI ChestSuite XR Pleural Effusion Assessment System— 510(k) K222076

Substantially Equivalent

Ever Fortune.Ai, Co., Ltd.

FDA 510(k) clearance K222076 for EFAI ChestSuite XR Pleural Effusion Assessment System, Substantially Equivalent on 2022-09-08. Applicant: Ever Fortune.Ai, Co., Ltd..

Clearance details

Applicant: Ever Fortune.Ai, Co., Ltd.
Product code: Code QFM
Advisory panel: Radiology
Date received: 2022-07-14
Decision date: 2022-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

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