ECHONET

K960946 · Lockheed Martin Communications Systems · LLZ · May 7, 1996 · Radiology

Device Facts

• Record ID: K960946
• Device Name: ECHONET
• Applicant: Lockheed Martin Communications Systems
• Product Code: LLZ · Radiology
• Decision Date: May 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

EchoNet is software which runs on Unix workstations. EchoNet is intended to be used for storing and displaying digital images acquired by digital ultrasound imaging systems. EchoNet provides rapid network access to the imagery and patient demographic data stored on a central server. The system retrieves and stores images as unaltered computer data and as JPEG (Joint Photographic Experts Group) lossy compressed cine-loops. This dual-path storage system allows for rapid access to high quality compressed images with the original unaltered (losslessly compressed) images available on demand. EchoNet is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users).

Device Story

EchoNet is a Unix-based software system for digital ultrasound image management; functions as a client-server architecture. Input: digital ultrasound images and patient demographics. Processing: server-side database management and virtual file system; client-side review software. Storage: dual-path system using JPEG lossy compression (Q-Factor 75, ~15:1 ratio) for rapid preview and lossless storage for on-demand retrieval. Output: displayed cine-loops and demographics on Unix workstations. Used by clinicians for preliminary assessment and diagnosis. Benefits: rapid network access to high-quality imagery across scalable hospital networks.

Clinical Evidence

No clinical data; bench testing only. Potential data handling risks addressed via Failure Mode and Effects Analysis (FMEA).

Technological Characteristics

Unix workstation-based software; client-server architecture. Supports mass storage devices including hard disks, optical jukebox libraries, and tape libraries. Image processing includes JPEG lossy compression (Q-Factor 75).

Indications for Use

Indicated for storage and display of digital ultrasound images and patient demographic data for clinical review and diagnosis in hospital or departmental settings.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Heartlab EchoNet (K954860)

Submission Summary (Full Text)

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K960946

# 510(k) Summary

MAY - 7 1996

## Identification of the Product

**Trade Name:** EchoNet
**Common Name:** Unknown
**Classification Name:** Device, Digital Image Storage

**Manufacturer:** Lockheed Martin
Communication Systems
1 Federal Street (A&E 1C)
Camden, NJ 08103
[phone]
[phone] (FAX)

**Contact Person:** Vincent J. Napoleon
**Date Prepared:** 06 March 1996

## Indications for Use:

EchoNet is software which runs on Unix workstations. EchoNet is intended to be used for storing and displaying digital images acquired by digital ultrasound imaging systems. EchoNet provides rapid network access to the imagery and patient demographic data stored on a central server. The system retrieves and stores images as unaltered computer data and as JPEG (Joint Photographic Experts Group) lossy compressed cine-loops. This dual-path storage system allows for rapid access to high quality compressed images with the original unaltered (losslessly compressed) images available on demand. EchoNet is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users).

## Device Descriptions:

EchoNet is composed of the following:

**EchoNet Client:** Unix workstation which permits review and diagnosis of ultrasound imagery and demographics. This review software provides basic controls such as play/pause, image contrast/brightness and image scaling. The system is capable of displaying two types of stored imagery. High quality JPEG compressed (Q-Factor 75 compression ratio approximately 15 to 1) digital cine-loops and unaltered digital cine-loops. The JPEG images are intended for preview and preliminary assessment while the original data is always available on demand.

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EchoNet Server: Unix workstation based database and image server software combined with a virtual file system. The server is a central archive for imagery and patient information. The EchoNet server may be configured with a variety of mass storage devices. These devices such as hard-disks, optical juke-box libraries and tape libraries provide on-line and archival storage of images.

## Marketing History

Lockheed Martin is about to begin marketing the EchoNet product. The EchoNet product, as to be marketed, is identical to the Heartlab EchoNet product described in a previous 510(k) submission with registration number K954860.

## Potential Adverse Effects on Health

The potential concerns (data handling) are controlled by Failure Mode and Effects Analysis (FMEA) to identify required controls.

## Conclusions

This system poses no added risk to safety.