# K182715: Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Wisonic Medical Technology Co., Ltd.
- Decided: Nov 20, 2018 after 54 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). 201 ancestors in all.
No later device cites it as a predicate yet.
0 of 202 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180461: Navi e/Navi s/Navi X Diagnostic Ultrasound System, Shenzhen Wisonic Medical Technology Co., Ltd. (2018) Summary page 24.

## 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/K182715
Methodology: https://510kreport.com/methodology