# K173962: Viamo c100 TUS-VC100 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Apr 20, 2018 after 113 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: 23 generations back to K935595 (1995). 199 ancestors in all.
No later device cites it as a predicate yet.
0 of 200 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170374: SonoBook Series Diagnostic Ultrasound System, Chison Medical Imaging Co., Ltd. (2017) Summary page 19.

## Indications for use
The Diagnostic Ultrasound System Viamo c100 Model TUS-VC100 is indicated for the visualization of structures, 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 (breast, thyroid, testes), transvaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult, pediatric), peripheral vascular, musculo-skeletal (conventional, superficial), and urology.

Source page: https://510kreport.com/device/K173962
Methodology: https://510kreport.com/methodology