EFAI NeuroSuite CT ICH Assessment System
FDA 510(k) K231025 · Ever Fortune.Ai, Co., Ltd.
Submission
- Device name
- EFAI NeuroSuite CT ICH Assessment System
- Applicant
- Ever Fortune.Ai, Co., Ltd.
Taichung City, TW - Received
- April 11, 2023
- Decision date
- October 4, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QAS – Radiological Computer-Assisted Triage And Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2080
- Specialty
- Radiology
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…
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Questions and answers
When was EFAI NeuroSuite CT ICH Assessment System cleared by the FDA?
EFAI NeuroSuite CT ICH Assessment System (K231025) received a 510(k) decision of Substantially Equivalent on October 4, 2023, 176 days after the submission was received.
What is the product code of K231025?
The FDA product code is QAS – Radiological Computer-Assisted Triage And Notification Software, a Class II (moderate risk) device regulated under 21 CFR 892.2080.