# K980060: Echolink

- Pathway: 510(k) (Traditional)
- Applicant: Mpacs, LLC
- Decided: Feb 25, 1998 after 49 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950279 (1995). 2 ancestors in all.
23 later devices descend from it; 5 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)
- K964803: Univision Echocardiology System, Network Concepts, Inc. (1997) Summary page 2.
- K950279: TOMTECP90, Tomtec Imaging Systems, Inc. (1995) Summary page 2.

## Most influential descendants
- 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
- K111319: Ibis Explorer and Markup Software (2011), 6 descendants of its own

## Indications for use
This device is intended for use by health care professionals trained in the field of echocardiography or medical ultrasound. It is to be used when there is a need to convert ultrasound analog video to a digital video format for subsequent review and archiving. This device is also intended for use in transferring ultrasound images over digital networks and/or digital communication lines.

Source page: https://510kreport.com/device/K980060
Methodology: https://510kreport.com/methodology