# K043189: Sonalis, Model 2000

- Pathway: 510(k) (Abbreviated)
- Applicant: 3g Ultrasound, Inc.
- Decided: Feb 9, 2005 after 84 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 K993092 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993092: Sonada Ultrasound System, Sonovision Corp. (2000) Summary page 1.

## Most influential descendants
- K153620: Enovare Ultrasound System (2016), 0 descendants of its own
- K100204: Sonalis (2010), 0 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K043189
Methodology: https://510kreport.com/methodology