FDA Cleared
New Device
✦ AI/ML Enabled (Radiology)
Pathway: 510K
EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)
Applicant:
Ever Fortune.Ai, Co., Ltd.
Statutory Profile
Legal Standard:
Substantial Equivalence (SE) to predicate (21 CFR 807)
Product Code:
QAS
Review Panel:
Radiology
21 CFR Regulation:
8
Review Velocity Metrics
Date Received:
2026-09-04
Decision Date:
2026-10-30
Total Review Duration:
56 calendar days (56 days)
Official FDA Research Backlinks
Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:
Identified Contacts & Correspondents
Joseph Chang
Role: SUBMITTER_CONTACT
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