# K071028: Viewmate System

- Pathway: 510(k) (Special)
- Applicant: Ep Medsystems
- Decided: May 1, 2007 after 20 days
- Product code: ITN (Splint, Denis Brown)
- Device class: 1
- Regulation: 21 CFR 890.3675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031066 (2003). 1 ancestor in all.
134 later devices descend from it; 1 cites it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031066: Viewmate Ultrasound Imaging System, Ep Medsystems (2003) Summary page 2.

## Most influential descendants
- K073709: Modification to Viewmate System (2008), 133 descendants of its own
- K101091: Z.One Ultra Ultrasound System (2010), 132 descendants of its own
- K121699: Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System (2012), 98 descendants of its own
- K123622: Acuson (2012), 96 descendants of its own
- K123001: Acuson X700 Diagnstic Ultrasound System (2012), 74 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.

Source page: https://510kreport.com/device/K071028
Methodology: https://510kreport.com/methodology