Data / Medical devices / United Kingdom / Mycardium Ai Ltd
Mycardium Ai Ltd: FDA-registered device maker in Liverpool, United Kingdom, 2 510(k) clearances
Mycardium Ai Ltd is registered with the FDA (registration 3030446846) in Liverpool, United Kingdom. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030446846
- Address
- The Spine Building 2 Paddington Village, Liverpool, United Kingdom, L73FA
- Owner or operator
- Mycardium AI Ltd (10089951)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 25, 2024
- Registered through
- 2026
- Brand names listed
- 1CMR Lite, 1CMR Pro, EchoConfidence
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 30, 2025 | K250670 | EchoConfidence (USA) | QIH | Substantially Equivalent | Mycardium AI Limited | accessdata.fda.gov |
| November 15, 2024 | K242062 | 1CMR Pro | LLZ | Substantially Equivalent | Mycardium AI Limited | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
Updated June 30, 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.