# K222745: Axial3D Insight

- Pathway: 510(k) (Traditional)
- Applicant: Axial Medical Printing Limited
- Decided: Jul 3, 2023 after 294 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924630 (1993). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221511: Axial3D Cloud Segmentation Service, Axial Medical Printing Limited (2022) Summary page 6.

## Most influential descendants
- K232841: Axial3D Insight (2023), 1 descendant of its own
- K250369: Axial3D Insight (2025), 0 descendants of its own

## Indications for use
Axial3DInsight is intended for use as a cloud-based service and image segmentation framework for the transfer of DICOM imaging information from a medical scanner to an output file. The Axial3DInsight output file can be used for the fabrication of physical replicas of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning. The output file or physical replica can be used for diagnostic purposes in the field of orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. Axial3DInsight should be used with other diagnostic tools and expert clinical judgment.

Source page: https://510kreport.com/device/K222745
Methodology: https://510kreport.com/methodology