# K250369: Axial3D Insight

- Pathway: 510(k) (Traditional)
- Applicant: Axial Medical Printing Limited
- Decided: Sep 18, 2025 after 220 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: 8 generations back to K924630 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232841: Axial3D Insight, Axial Medical Printing Limited (2023) Summary page 5.

## Indications for use
Axial3D Insight 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 Axial3D Insight 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 the physical replica can be used for diagnostic purposes in the field of trauma, orthopedic, maxillofacial and cardiovascular applications. Axial3D Insight should be used in conjunction with other diagnostic tools and expert clinical judgment.

Source page: https://510kreport.com/device/K250369
Methodology: https://510kreport.com/methodology