# K993092: Sonada Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonovision Corp.
- Decided: Apr 14, 2000 after 211 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K043189: Sonalis, Model 2000 (2005), 2 descendants of its own
- 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: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K993092
Methodology: https://510kreport.com/methodology