# K173265: UltraVision 2 Diagnostic Ultrasound System

- Pathway: 510(k) (Abbreviated)
- Applicant: Winprobe Corporation
- Decided: Nov 7, 2017 after 27 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K935595 (1995). 177 ancestors in all.
2 later devices descend 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)
- K142876: ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2014) Summary page 8.

## Most influential descendants
- K190039: EchoSure Diagnostic Ultrasound System (2019), 1 descendant of its own
- K243479: EchoGuide (Version 1) (2025), 0 descendants of its own

## Indications for use
This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients, (thyroid, breast, and testicles) and for peripheral vessel, abdominal, and superficial muscular skeletal diagnosis. The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.

Source page: https://510kreport.com/device/K173265
Methodology: https://510kreport.com/methodology