# K163443: Interson USB Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Interson Corporation
- Decided: Apr 13, 2017 after 126 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: 18 generations back to K935595 (1995). 173 ancestors in all.
3 later devices descend from it; 3 cite it directly.
6 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152899: Philips Lumify Diagnostic Ultrasound System, Philips Healthcare, Inc. (2015) Summary page 8.
- K070907: Interson Usb Ultrasound Probe System, Regulatory Management Services (2007) Summary page 8.

## Most influential descendants
- K233734: Interson USB Ultrasound System (2023), 0 descendants of its own
- K192170: VistaScan USB Ultrasound Imaging System (2020), 0 descendants of its own
- K192573: Dolphin Medical Imaging USB Ultrasound System (2019), 0 descendants of its own

## Indications for use
The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B, color Doppler, or Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis 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 healthcare professionals.

Source page: https://510kreport.com/device/K163443
Methodology: https://510kreport.com/methodology