# Smartcardia SA

- Location (FDA's records): Lausanne, CH
- FDA decisions: 2 (2023–2024): 2 510(k) clearances
- Product codes: QYX (1), DSI (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 1 (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
- KANEKA Corporation: 1 (https://510kreport.com/company/kaneka)
- Vitalconnect, Inc.: 1 (https://510kreport.com/company/vitalconnect)
- Infobionic, Inc.: 1 (https://510kreport.com/company/infobionic)

## Firms that cite its devices most
- Boston Scientific Cardiac Diagnostic Technologies, Inc.: 1 (https://510kreport.com/company/boston-scientific-cardiac-diagnostic-technologies)

## Its most-cited devices
- K240653: SmartCardia 7L Platform (MCT) (2024), cited by 1

## Recent decisions
- K240653: SmartCardia 7L Platform (MCT) (Oct 31, 2024)
- K231276: SmartCardia 7L Platform (Aug 30, 2023)

Source page: https://510kreport.com/company/smartcardia