# K180461: Navi e/Navi s/Navi X Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Wisonic Medical Technology Co., Ltd.
- Decided: May 9, 2018 after 78 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: 23 generations back to K935595 (1995). 200 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 202 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143472: TE7 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 24.

## Most influential descendants
- K182715: Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System (2018), 0 descendants of its own

## Indications for use
The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes,thyroid,etc.),neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.

Source page: https://510kreport.com/device/K180461
Methodology: https://510kreport.com/methodology