K231607
- 510(k) number
- K231607
- Device name
- Axial3D Cloud Segmentation Service
- Applicant
- Axial Medical Printing Limited GB
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2024-01-24
- Date received
- 2023-06-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231607.pdf
Official FDA record: K231607
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.