EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)— 510(k) K263109
Substantially EquivalentEver Fortune.Ai, Co., Ltd.
FDA 510(k) clearance K263109 for EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100), Substantially Equivalent on 2026-10-30. Applicant: Ever Fortune.Ai, Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Ever Fortune.Ai, Co., Ltd.
- Product code
- Product code QAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung City, TW
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Data sourced from openFDA. This site is unofficial and independent of the FDA.