# K103608: I3 System-Abd Diagnostic Ultrasound

- Pathway: 510(k) (Special)
- Applicant: Ellex, Inc.
- Decided: Dec 27, 2010 after 18 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
Longest line of descent: 1 generation back to K083061 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083061: Ellex Innovative Imaging Eye Cubed V4, Ellex, Inc. (2009) Summary page 5.

## Indications for use
The Eye Cubed V4 is indicated for use in ophthalmic imaging when the following conditions are present or suspected: Cataracts Retinal Detachments (a separation of the retina from the middle coat of the eyeball) Orbital Lesions Tumors. Foreign bodies Inflammation Vascular Irregularities

Source page: https://510kreport.com/device/K103608
Methodology: https://510kreport.com/methodology