# K190039: EchoSure Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonavex, Inc.
- Decided: Mar 8, 2019 after 59 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: 21 generations back to K935595 (1995). 178 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173265: UltraVision 2 Diagnostic Ultrasound System, Winprobe Corporation (2017) Summary page 5.

## Most influential descendants
- K243479: EchoGuide (Version 1) (2025), 0 descendants of its own

## Indications for use
The EchoSure diagnostic ultrasound system and its transducer are intended for use in clinical examinations of blood vessels that are marked with an EchoMark or EchoMark LP implant. The system provides measurements and information about blood flow. The system is intended for use by trained medical health care professionals in support of clinical diagnosis.

Source page: https://510kreport.com/device/K190039
Methodology: https://510kreport.com/methodology