Data / Medical devices / Automated Radiological Image Processing Software / United Kingdom
FDA-registered makers of Automated Radiological Image Processing Software in the United Kingdom: 6 establishments
6 establishments in the United Kingdom are registered with the FDA to make Automated Radiological Image Processing Software (product code QIH). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Automated Radiological Image Processing Software
- Product code
- QIH
- Country
- United Kingdom
Makers of Automated Radiological Image Processing Software in the United Kingdom
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Axial Medical Printing Limited | Belfast, United Kingdom | Manufacturer | 3 | September 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ultromics, Ltd. | Oxford Oxfordshire, United Kingdom | Complaint file establishment, Manufacturer | 2 | December 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Brainomix Limited | Oxford Oxfordshire, United Kingdom | Complaint file establishment, Manufacturer | 1 | June 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Mycardium Ai Ltd | Liverpool, United Kingdom | Complaint file establishment, Manufacturer | 1 | June 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Oxford Brain Diagnostics, Ltd. | Oxford, United Kingdom | Manufacturer | 1 | December 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Topia Medtech Limited | Welwyn Garden City Herefordshire, United Kingdom | Manufacturer | 1 | December 19, 2025 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.