# K133277: XARIO 100

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Jan 17, 2014 after 85 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: 17 generations back to K935595 (1995). 133 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131507: Xario 200 Diagnostic Ultrasound System, Toshibamedical Systems Corporation (2013) Summary page 2.

## Most influential descendants
- K143046: Xario 100, V3.0 (2014), 1 descendant of its own
- K162187: Xario 100 Diagnostic Ultrasound System, V5.0 (2016), 0 descendants of its own

## Indications for use
The Diagnostic Ultrasound System Xario 100 Model TUS-X 100 and TUS-X 100S 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, pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, and musculo-skeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K133277
Methodology: https://510kreport.com/methodology