# K191347: Paragon XHD Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Wisonic Medical Technology Co., Ltd.
- Decided: Feb 7, 2020 after 263 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: 22 generations back to K935595 (1995). 187 ancestors in all.
No later device cites it as a predicate yet.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160674: Fujifilm Sonosite Vevo MD Imaging System, FUJIFILM Sonosite, Inc. (2016) Summary page 4.
- K163712: Clover 50/Clover60/Clover70 Diagnostic Ultrasound System, Shenzhen Wisonic Medical Technology Co., Ltd. (2018) Summary page 4.

## Indications for use
The Diagnostic Ultrasound System is applicable for adults and pediatric patients. It is intended for use in pediatric, small organ (breast, thyroid, testicles, prostate), musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and dermatological exams.

Source page: https://510kreport.com/device/K191347
Methodology: https://510kreport.com/methodology