EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)— 510(k) K234042
Substantially EquivalentEver Fortune.Ai, Co., Ltd.
FDA 510(k) clearance K234042 for EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100), Substantially Equivalent on 2024-06-07. Applicant: Ever Fortune.Ai, Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Ever Fortune.Ai, Co., Ltd.
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung City, TW
Recent devices under product code QIH
view allMore clearances from Ever Fortune.Ai, Co., Ltd.
view all- K253163 — EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
- K251306 — Seg Pro V3 (RT-300)
- K242821 — EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
- K241923 — EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
- K240291 — EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.