Axial3D Cloud Segmentation Service— 510(k) K231607
Substantially EquivalentAxial Medical Printing Limited
FDA 510(k) clearance K231607 for Axial3D Cloud Segmentation Service, Substantially Equivalent on 2024-01-24. Applicant: Axial Medical Printing Limited.
Clearance details
- Applicant
- Axial Medical Printing Limited
- Product code
- Code LLZ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Belfast, GB
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.