# K150580: UltraVision 2 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Winprobe Corporation
- Decided: Apr 7, 2015 after 29 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: 12 generations back to K935595 (1995). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081148: Siemens Acuson 2000 Ultrasound System with Abvs Transducer, Siemens Medical Solutions USA, Inc., Ultrasound DI (2008) Summary page 7.

## 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 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/K150580
Methodology: https://510kreport.com/methodology