# Mycardium AI Limited

- Location (FDA's records): Liverpool, GB
- FDA decisions: 2 (2024–2025): 2 510(k) clearances
- Product codes: QIH (1), LLZ (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Eko.Ai Pte Ltd. D/B/A Us2.Ai: 1 (https://510kreport.com/company/eko-ai-d-b-a-us2-ai)
- Ultromics Limited: 1 (https://510kreport.com/company/ultromics)
- Ai4medimaging Medical Solutions S.A.: 1 (https://510kreport.com/company/ai4medimaging-medical-solutions)
- Circle Cardiovascular Imaging, Inc.: 1 (https://510kreport.com/company/circle-cardiovascular-imaging)

## Recent decisions
- K250670: EchoConfidence (USA) (Jun 30, 2025)
- K242062: 1CMR Pro (Nov 15, 2024)

Source page: https://510kreport.com/company/mycardium-ai