# K131507: Xario 200 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Aug 28, 2013 after 96 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: 16 generations back to K935595 (1995). 132 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123992: Aplio 500/400/300 V3.0, Toshibamedical Systems Corporation (2013) Summary page 16.

## Most influential descendants
- K143027: Xario 200, V3.0 (2014), 5 descendants of its own
- K162155: Xario 200 Diagnostic Ultrasound System V5.0 (2016), 4 descendants of its own
- 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
- K133277: XARIO 100 (2014), 2 descendants of its own

## Indications for use
The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and 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), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculo- skeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K131507
Methodology: https://510kreport.com/methodology