# K964803: Univision Echocardiology System

- Pathway: 510(k) (Traditional)
- Applicant: Network Concepts, Inc.
- Decided: Feb 11, 1997 after 74 days
- Product code: LMB (Device, Digital Image Storage, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2010
- 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 K950279 (1995). 1 ancestor in all.
24 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950279: TOMTECP90, Tomtec Imaging Systems, Inc. (1995) Summary page 1.

## Most influential descendants
- K980060: Echolink (1998), 23 descendants of its own
- K023772: Kinetdx Picture Archiving and Communications System (2002), 16 descendants of its own
- K992259: Echocardiography System Series 95000 (1999), 16 descendants of its own
- K041029: Kinetdx (2004), 13 descendants of its own
- K053133: Syngo Dynamics, Version 5.0 (2005), 7 descendants of its own

## Indications for use
The UNIVISION™ Echocardiology System is a network system intended to use digital technology to acquire images from an echocardiogaphy ultrasound system for viewing outside the exam room and long term storage and retrieval on digital media.

Source page: https://510kreport.com/device/K964803
Methodology: https://510kreport.com/methodology