# K231607: Axial3D Cloud Segmentation Service

- Pathway: 510(k) (Special)
- Applicant: Axial Medical Printing Limited
- Decided: Jan 24, 2024 after 237 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: 6 generations back to K924630 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 4.

## Indications for use
Axial3D Cloud Segmentation Service 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, which 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 and/or diagnostic purposes in the field of orthopedic, maxillofacial, and cardiovascular applications in adults. The output file or physical replica may also be used for pediatrics between the ages of 12 and 21 years of age in cardiovascular applications. Axial3D Cloud Segmentation Service should be used with other diagnostic tools and expert clinical judgment.

Source page: https://510kreport.com/device/K231607
Methodology: https://510kreport.com/methodology