# K192573: Dolphin Medical Imaging USB Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Dolphin Medical Imaging, LLC
- Decided: Nov 19, 2019 after 62 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 5.

## Indications for use
The Dolphin Medical Imaging USB Ultrasound System is intended for diagnostic ultrasound imaging in B mode. It is indicated for diagnostic ultrasound imaging in the following applications: • Fetal/Obstetric • Abdominal Pediatric • Small Organ • Musculo-skeletal (conventional) • Musculo-skeletal (superficial) • Urology • Gynecology • Pelvic Floor • Neuro-muscular • Peripheral Vessel The system is intended for use by trained registered nurses and other trained healthcare professionals in a professional healthcare environment.

Source page: https://510kreport.com/device/K192573
Methodology: https://510kreport.com/methodology