# Hi-D Imaging AG

- Location (FDA's records): Winterthur, CH
- FDA decisions: 2 (2025–2026): 2 510(k) clearances
- Product codes: QIH (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 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
- Pie Medical Imaging BV: 1 (https://510kreport.com/company/pie-medical-imaging)

## Its most-cited devices
- K241984: Hi-D Imaging 4TAVR (2025), cited by 1

## Recent decisions
- K261535: Hi-D Imaging 4TAVR (Jul 20, 2026)
- K241984: Hi-D Imaging 4TAVR (Apr 2, 2025)

Source page: https://510kreport.com/company/hi-d-imaging