Data / Medical devices / United Kingdom / Axial Medical Printing Limited
Axial Medical Printing Limited: FDA-registered device maker in Belfast, United Kingdom, 5 510(k) clearances
Axial Medical Printing Limited is registered with the FDA (registration 3016824824) in Belfast, United Kingdom. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3016824824
- Address
- 17A Ormeau Avenue, Belfast, United Kingdom, BT2 8HD
- Owner or operator
- Axial Medical Printing Limited (10071504)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 22, 2020
- Registered through
- 2026
- Brand names listed
- Axial Cloud Segmentation Service, Axial3D Cloud Segmentation Service, Axial3D Insight, COVID swabs
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Specification developer | accessdata.fda.gov |
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 18, 2025 | K250369 | Axial3D Insight | QIH | Substantially Equivalent | Axial Medical Printing Limited | accessdata.fda.gov |
| January 24, 2024 | K231607 | Axial3D Cloud Segmentation Service | LLZ | Substantially Equivalent | Axial Medical Printing Limited | accessdata.fda.gov |
| November 15, 2023 | K232841 | Axial3D Insight | QIH | Substantially Equivalent | Axial Medical Printing Limited | accessdata.fda.gov |
| July 3, 2023 | K222745 | Axial3D Insight | QIH | Substantially Equivalent | Axial Medical Printing Limited | accessdata.fda.gov |
| June 23, 2022 | K221511 | Axial3D Cloud Segmentation Service | LLZ | Substantially Equivalent | Axial Medical Printing Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
- All makers of Applicator, Absorbent Tipped, Non-Sterile
Updated September 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.