# K072918: Model Ssa-680A Xario XG Diagnostic Ultrasound System, Version 1.00

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Oct 29, 2007 after 14 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894632 (1989). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072000: Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0, Toshiba America Medical Systems, In.C (2007) Summary page 1.

## Recalls of this device
- Aug 5, 2013 · Class II · Z-0120-2014: The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mo
- Jan 5, 2010 · Not classified · Z-1997-2010: Toshiba America Medical Systems is initiating a field correction on the PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems due to an incorrect sweep direction set
- May 11, 2009 · Not classified · Z-1100-2010: Toshiba America Medical Systems Inc is removing the PET-511BTM Multi-plane Transesophageal Transducer from the market after receiving several reports of injury regarding the transducer. Bending or buc

## Indications for use
The Xario XG is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K072918
Methodology: https://510kreport.com/methodology