# K032324: Echoencoder

- Pathway: 510(k) (Traditional)
- Applicant: Icardiogram, Incorporated
- Decided: Oct 2, 2003 after 66 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: 4 generations back to K955092 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990052: Tel-Echo System, Innovative Medical Solutions, Inc. (1999) Summary page 1.
- K980060: Echolink, Mpacs, LLC (1998) Summary page 1.

## Indications for use
The device is intended to be used by health care professionals in the field of echocardiography. The device is capable of transferring ultrasound images over long distances as digital files. It is used to transmit echocardiograms over the Internet for the purpose of interpretation of echocardiograms at a remote location. It is anticipated that it will be used when echocardiograms must be performed in a location where no interpreting cardiologist is present, and will facilitate prompt interpretation of echocardiograms. It should be particularly useful in rural areas of the United States.

Source page: https://510kreport.com/device/K032324
Methodology: https://510kreport.com/methodology