# K031066: Viewmate Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ep Medsystems
- Decided: Oct 17, 2003 after 197 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
No predicates in its family tree.
691 later devices descend from it; 5 cite it directly.
0 of 692 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K062247: HD11 Diagnostic Ultrasound System (2006), 687 descendants of its own
- K080935: Sonix MDP Ultrasound Scanner (2008), 584 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own
- K110943: Logiq E9 (2011), 472 descendants of its own

## Indications for use
The ViewMate@System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart. The ViewMate8System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

Source page: https://510kreport.com/device/K031066
Methodology: https://510kreport.com/methodology