# K221511: Axial3D Cloud Segmentation Service

- Pathway: 510(k) (Traditional)
- Applicant: Axial Medical Printing Limited
- Decided: Jun 23, 2022 after 30 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 5 generations back to K924630 (1993). 6 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173619: Mimics inPrint, Materialise NV (2018) Summary page 5.

## Most influential descendants
- K222745: Axial3D Insight (2023), 2 descendants of its own
- K232841: Axial3D Insight (2023), 1 descendant of its own
- K250369: Axial3D Insight (2025), 0 descendants of its own
- K231607: Axial3D Cloud Segmentation Service (2024), 0 descendants of its own

## Indications for use
Axial3D Cloud Segmentation Service is intended for use as a cloud based service and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. The Axial3D Cloud Segmentation Service 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 physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Axial3D Cloud Segmentation Service should be used in conjunction with other diagnostic tools and expert clinical judgment.

Source page: https://510kreport.com/device/K221511
Methodology: https://510kreport.com/methodology