EFAI NeuroSuite CT ICH Assessment System— 510(k) K231025
Substantially EquivalentEver Fortune.Ai, Co., Ltd.
FDA 510(k) clearance K231025 for EFAI NeuroSuite CT ICH Assessment System, Substantially Equivalent on 2023-10-04. Applicant: Ever Fortune.Ai, Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Ever Fortune.Ai, Co., Ltd.
- Product code
- 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
Recent devices under product code QAS
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- K234042 — EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
- K240291 — EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.