# K100067: Model Viamo Ssa-640A, Version 2.0 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jan 28, 2010 after 17 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K894632 (1989). 58 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093171: Viamo  Ssa-640A Version 1.2, Toshiba America Medical Systems, In.C (2009) Summary page 1.
- K091295: Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0, Toshiba America Medical Systems, In.C (2009) Summary page 1.

## Most influential descendants
- K122491: Viamo Ssa-640A V4.0 (2012), 0 descendants of its own

## Indications for use
The Viamo SSA-640 v2.0 Ultrasound System is indicated for the visualization of structures, characteristics, 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, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, and musculo-skeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K100067
Methodology: https://510kreport.com/methodology