# K192253: SonicEye Dual-Array Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonivate Medical, Inc.
- Decided: Feb 25, 2020 after 189 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: 16 generations back to K935595 (1995). 127 ancestors in all.
No later device cites it as a predicate yet.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140693: Vscan with Dual Probe, Ge Medical Sysyems Ultrasound & Primary Care Diagn (2014) Summary page 4.

## Indications for use
The SonicEye® Dual-Array Ultrasound System is for use in B-mode (grayscale) imaging of human subjects in the following clinical applications: Fetal, Cardiac (adult and pediatric), Abdominal, Pediatric, Peripheral vessel, Musculoskeletal (conventional and superficial), Small parts (breast, thyroid, testes), Thoracic/pleural. The device is intended for use by medical professionals to include doctors, imaging technicians, emergency medicine and military corpsmen/medics that have been trained in basic sonography techniques. The use would include medical environments such as hospitals, clinics, military field aid stations.

Source page: https://510kreport.com/device/K192253
Methodology: https://510kreport.com/methodology