# K083061: Ellex Innovative Imaging Eye Cubed V4

- Pathway: 510(k) (Abbreviated)
- Applicant: Ellex, Inc.
- Decided: Jan 9, 2009 after 87 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K103608: I3 System-Abd Diagnostic Ultrasound (2010), 0 descendants of its own

## Indications for use
Posterior 10MHz B-scan Imaging of the Eye 10MHz Biometric A-scan Imaging of the Eye 8MHz Diagnostic A-scan Imaging of the Eye Anterior 20MHz B-scan Imaging of the Eye

Source page: https://510kreport.com/device/K083061
Methodology: https://510kreport.com/methodology