K232841
- 510(k) number
- K232841
- Device name
- Axial3D Insight
- Applicant
- Axial Medical Printing Limited GB
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2023-11-15
- Date received
- 2023-09-14
- 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: K232841.pdf
Official FDA record: K232841
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.