# K030242: Fyrelink

- Pathway: 510(k) (Traditional)
- Applicant: Mpacs, LLC
- Decided: Mar 10, 2003 after 46 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: 3 generations back to K950279 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980060: Echolink, Mpacs, LLC (1998) Summary page 2.
- K954668: HP Echo Image Management System, Hewlett-Packard Co. (1995) Summary page 2.
- K950279: TOMTECP90, Tomtec Imaging Systems, Inc. (1995) Summary page 2.

## 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 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/K030242
Methodology: https://510kreport.com/methodology