# 3D Ultrasound, Inc.

- Location (FDA's records): Durham, NC
- FDA decisions: 2 (1995–1997): 2 510(k) clearances
- Product codes: IYO (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (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 that cite its devices most
- Volumetrics Medical Imaging, Inc.: 2 (https://510kreport.com/company/volumetrics-medical-imaging)

## Its most-cited devices
- K952551: Janus I (1995), cited by 1
- K963863: Janus I (1997), cited by 1

## Recent decisions
- K963863: Janus I (Apr 21, 1997)
- K952551: Janus I (Dec 11, 1995)

Source page: https://510kreport.com/company/3d-ultrasound