# K122491: Viamo Ssa-640A V4.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Sep 13, 2012 after 29 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: 14 generations back to K894632 (1989). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100067: Model Viamo Ssa-640A, Version 2.0 Ultrasound System, Toshiba America Medical Systems, In.C (2010) Summary page 2.

## Indications for use
The VIAMO Diagnostic 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/K122491
Methodology: https://510kreport.com/methodology