K250369
- 510(k) number
- K250369
- Device name
- Axial3D Insight
- Applicant
- Axial Medical Printing Limited GB
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-09-18
- Date received
- 2025-02-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250369.pdf
Official FDA record: K250369
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.