510(k) clearance
EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)
- 510(k) number
- K263109
- Applicant
- Ever Fortune.Ai, Co., Ltd.
- Decision date
- Oct 30, 2026
- Date received
- Sep 4, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QAS
- Device type
- Radiological Computer-Assisted Triage And Notification Software
- Device class
- Class II
- Regulation
- 21 CFR 892.2080
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Taichung City, TW