# K233734: Interson USB Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Interson Corporation
- Decided: Dec 22, 2023 after 30 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: 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 6.

## Indications for use
The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B, color Doppler, M mode 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 Trans-Rectal Trans-Vaginal Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Cardiac Peripheral Vessel The system is intended for use by trained healthcare professionals having a general knowledge of the use of ultrasound imaging devices and imaging protocols in environments where healthcare is provided by healthcare professionals.

Source page: https://510kreport.com/device/K233734
Methodology: https://510kreport.com/methodology