# K192170: VistaScan USB Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Emagine Solutions Technology, LLC
- Decided: Jan 23, 2020 after 164 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: 19 generations back to K935595 (1995). 174 ancestors in all.
No later device cites it as a predicate yet.
6 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163443: Interson USB Ultrasound System, Interson Corporation (2017) Summary page 4.
- K070907: Interson Usb Ultrasound Probe System, Regulatory Management Services (2007) Summary page 4.

## Indications for use
The VistaScan™ USB Ultrasound Imaging System is intended for diagnostic ultrasound imaging in B mode for the following applications: Fetal/obstetric Gynecology Abdominal Pediatric Small organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Pelvic floor Neuro-muscular Peripheral vessel Indications for use vary by probe type. The VistaScan™ USB Ultrasound Imaging System is indicated for Rx (prescription) use and intended for use by appropriately trained healthcare professionals such as physicians and ultrasound technologists. The VistaScan™ USB Ultrasound Imaging System is intended for use in healthcare facilities such as hospitals, clinics and facilities where ultrasound testing is performed.

Source page: https://510kreport.com/device/K192170
Methodology: https://510kreport.com/methodology