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Sign in to claim this brandMycardium AI Limited
US
Last updated May 30, 2026
What Mycardium AI Limited makes
Mycardium AI Limited develops software applications for cardiac mapping and MRI image interpretation, including tools designed to assist in electroanatomical mapping of the heart and automated analysis of cardiac MRI scans. Their portfolio includes solutions for improving diagnostic confidence in echocardiograms and specialized software for analyzing cardiac magnetic resonance imaging data.
The company’s products are classified as Class II medical devices under US regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These software applications are intended for use in clinical settings within the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Mycardium AI Limited manufacture?
Mycardium AI Limited specializes in developing software applications for cardiac diagnostics. Their primary offerings include cardiac mapping system software, which aids in electroanatomical mapping of the heart, and MRI image interpretive software, such as tools for automated analysis of cardiac MRI scans. These solutions are designed to enhance diagnostic accuracy and efficiency in clinical settings.
Where is Mycardium AI Limited based, and where are their devices intended for use?
Mycardium AI Limited is based in the United States. Their devices are specifically intended for use in clinical settings within the US, as indicated by their regulatory listings and device classifications.
Which regulatory registries list Mycardium AI Limited’s devices?
Mycardium AI Limited’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries help track and identify their software applications, which are classified as Class II medical devices under US regulations.
How are Mycardium AI Limited’s devices classified under US regulations?
Mycardium AI Limited’s devices are classified as Class II medical devices in the US. This classification is based on their intended use in assisting with cardiac diagnostics, such as electroanatomical mapping and MRI image interpretation, which pose moderate risk and require regulatory oversight to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 228840878
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mycardium | 010002 | FDA UDI | Class II | Active |
| Mycardium | 01.01.00(USA) | FDA UDI | Class II | Active |
| EchoConfidence (USA) | K250670 | FDA 510(k) | Class II | Active |
| 1CMR Pro | K242062 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Mycardium Ai Ltd Liverpool · GB FEI 3030446846