FDA 510(k) Applications Submitted by Ever Fortune.AI, Co., Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K241923 07/01/2024 EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) Ever Fortune.AI, Co., Ltd.
K242821 09/18/2024 EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) Ever Fortune.AI, Co., Ltd.
K240291 02/01/2024 EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM Ever Fortune.AI, Co., Ltd.


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