# K162155: Xario 200 Diagnostic Ultrasound System V5.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Nov 1, 2016 after 91 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 134 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143027: Xario 200, V3.0, Toshibamedical Systems Corporation (2014) Summary page 4.

## Most influential descendants
- K172276: Xario 200 Diagnostic Ultrasound System V6.0 (2017), 3 descendants of its own
- K182596: Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System (2018), 2 descendants of its own
- K232988: Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System (2023), 0 descendants of its own
- K202737: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System (2020), 0 descendants of its own

## Recalls of this device
- May 1, 2017 · Class II · Z-2709-2017: When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workst

## Indications for use
The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small organs, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

Source page: https://510kreport.com/device/K162155
Methodology: https://510kreport.com/methodology