# Oni, Inc.

- Location (FDA's records): North Andover, MA
- FDA decisions: 1 (2000–2000): 1 510(k) clearance
- Product codes: LNH (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Aspect Imaging, Ltd.: 1 (https://510kreport.com/company/aspect-imaging)
- Oni Medical Systems, Inc.: 1 (https://510kreport.com/company/oni-medical-systems)

## Its most-cited devices
- K001773: Orthone (2000), cited by 2

## Recent decisions
- K001773: Orthone (Aug 18, 2000)

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