Cleared Traditional

EFAI NeuroSuite CT ICH Assessment System

K231025 · Ever Fortune.Ai, Co., Ltd. · Radiology

Oct 2023

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K231025 is an FDA 510(k) clearance for the EFAI NeuroSuite CT ICH Assessment System, 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 October 4, 2023, 176 days after receiving the submission on April 11, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2080.

Submission Details

510(k) Number	K231025 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2023
Decision Date	October 04, 2023
Days to Decision	176 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 .