K234042
- 510(k) number
- K234042
- Device name
- EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
- Applicant
- Ever Fortune.Ai, Co., Ltd. TW
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-06-07
- Date received
- 2023-12-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K234042.pdf
Official FDA record: K234042
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.