K231928
- 510(k) number
- K231928
- Device name
- EFAI RTSUITE CT HCAP-Segmentation System
- Applicant
- Ever Fortune.Ai, Co., Ltd. TW
- Product code
- QKB — Radiological Image Processing Software For Radiation
- Decision date
- 2023-09-25
- Date received
- 2023-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231928.pdf
Official FDA record: K231928
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.