# K252709: Wireless Probe Type Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Xuzhou Yongkang Electronic Science Technology Co., Ltd.
- Decided: Apr 2, 2026 after 218 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: 24 generations back to K935595 (1995). 217 ancestors in all.
No later device cites it as a predicate yet.
6 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242681: NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25), Nurodata, Inc. (2025) Summary page 5.

## Indications for use
The Wireless Probe Type Ultrasound Scanner is a portable and software-based ultrasound imaging system, indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: PIU1A,PEU1A,PIU1C,PEU1C,PAU2C: Small Organ, Musculo-skeletal(Conventional and Superficial) , Peripheral vessels PIU1B,PEU1B: Fetal, Abdominal, Pediatric, Ob/GYN, Urology; PIU1D,PEU1D: Fetal, Abdominal, Pediatric, Ob/GYN, Urology, Cardiac Adult, Cardiac Pediatric; PIU2A,PEU2A, PAU2A: Small Organ, Musculo-skeletal(Conventional and Superficial) , Peripheral vessels, Fetal, Abdominal, Pediatric, Ob/GYN, Urology; PIU2B,PEU2B, PAU2B: Small Organ, Musculo-skeletal(Conventional and Superficial), Peripheral vessels, Fetal, Abdominal, Pediatric, Ob/GYN, Urology, Cardiac Adult, Cardiac Pediatric;

Source page: https://510kreport.com/device/K252709
Methodology: https://510kreport.com/methodology