# K050380: Xario Diagnostic Ultrasound System, Model Ssa-660A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Feb 23, 2005 after 8 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K894632 (1989). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041499: Ssa-770A, Aplio Version 5.5, Toshibamedical Systems Corporation (2004) Summary page 1.

## Recalls of this device
- Aug 5, 2013 · Class II · Z-0119-2014: 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
- Nov 12, 2007 · Not classified · Z-1173-2010: Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA

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

Source page: https://510kreport.com/device/K050380
Methodology: https://510kreport.com/methodology