EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)— 510(k) K241923

Name: FDA 510(k) clearance K241923
Creator: U.S. Food and Drug Administration
Published: 2024-12-06

Substantially Equivalent

Ever Fortune.Ai, Co., Ltd.

FDA 510(k) clearance K241923 for EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100), Substantially Equivalent on 2024-12-06. Applicant: Ever Fortune.Ai, Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ever Fortune.Ai, Co., Ltd.
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2024-07-01
Decision date: 2024-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

Download summary PDF View on FDA.gov ↗

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