# K093171: Viamo  Ssa-640A Version 1.2

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Dec 4, 2009 after 57 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: 12 generations back to K894632 (1989). 57 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K142197: Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2 (2014), 5 descendants of its own
- K151060: Ultrasound System SONIMAGE HS1 (2015), 4 descendants of its own
- K152577: Ultrasound System Sonimage HS 1 (2015), 3 descendants of its own
- K162065: Ultrasound System SONIMAGE HS1 (2016), 2 descendants of its own
- K103148: Aida Diagnostic Ultrasound System (2011), 2 descendants of its own

## Indications for use
The Viamo SSA-640 vl.2 Ultrasound System is indicated for the visualization of structures, characteristics, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, peripheral vascular and musculo-skeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K093171
Methodology: https://510kreport.com/methodology