K240291
- 510(k) number
- K240291
- Device name
- EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
- Applicant
- Ever Fortune.Ai, Co., Ltd. TW
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2024-04-08
- Date received
- 2024-02-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K240291.pdf
Official FDA record: K240291
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.