# K162187: Xario 100 Diagnostic Ultrasound System, V5.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Sep 30, 2016 after 57 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: 19 generations back to K935595 (1995). 135 ancestors in all.
No later device cites it as a predicate yet.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143046: Xario 100, V3.0, Toshibamedical Systems Corporation (2014) Summary page 4.

## Recalls of this device
- May 1, 2017 · Class II · Z-2708-2017: 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 100 Model TUS-X100 is 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/K162187
Methodology: https://510kreport.com/methodology