Cleared Traditional

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

K241923 · Ever Fortune.Ai, Co., Ltd. · Radiology

Dec 2024

Decision

158d

Days

Class 2

Risk

About This 510(k) Submission

K241923 is an FDA 510(k) clearance for the EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100), a Radiological Computer-assisted Triage And Notification Software (Class II — Special Controls, product code QAS), submitted by Ever Fortune.Ai, Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on December 6, 2024, 158 days after receiving the submission on July 1, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2080.

Submission Details

510(k) Number	K241923 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2024
Decision Date	December 06, 2024
Days to Decision	158 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	QAS — Radiological Computer-assisted Triage And Notification Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2080
Definition	Radiological Computer-assisted Triage And Notification Software Is An Image Processing Device Intended To Aid In Prioritization And Triage Of Time Sensitive Patient Detection And Diagnosis Based On The Analysis Of Medical Images Acquired From Radiological Signal Acquisition Systems. The Device Identifies Or Prioritizes Time Sensitive Imaging For Review By Prespecified Clinical Users Based On Software-based Image Analysis But Does Not Provide Information From The Image Analysis Other Than Triage And Notification .