# Ellex, Inc.

- Location (FDA's records): Sacramento, CA
- FDA decisions: 2 (2009–2010): 2 510(k) clearances
- Product codes: IYO (2)
- Predicates its devices cite: 1 (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

## Its most-cited devices
- K083061: Ellex Innovative Imaging Eye Cubed V4 (2009), cited by 1

## Recent decisions
- K103608: I3 System-Abd Diagnostic Ultrasound (Dec 27, 2010)
- K083061: Ellex Innovative Imaging Eye Cubed V4 (Jan 9, 2009)

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