COMPUMED DICON CLIENT

K955708 · Compumed, Inc. · LMD · Mar 1, 1996 · Radiology

Device Facts

• Record ID: K955708
• Device Name: COMPUMED DICON CLIENT
• Applicant: Compumed, Inc.
• Product Code: LMD · Radiology
• Decision Date: Mar 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The CompuMed DICOM client is an on-site (LAN) or off-site (WAN or dial up) station for viewing patient information and images and reporting. It supports industry standard information transmission and communication protocols.

Device Story

CompuMed DICOM client; viewing workstation for medical imaging. Inputs: patient information and images via LAN, WAN, or dial-up. Function: supports industry-standard DICOM transmission and communication protocols; enables on-site or off-site image viewing and reporting. Output: displayed patient images and reports for clinician review. Used by radiologists/clinicians in clinical settings to facilitate teleradiology and study information distribution. Benefits: enables remote access to diagnostic images and reporting, improving workflow efficiency and clinical decision-making speed.

Clinical Evidence

No clinical data provided; device is a viewing workstation for medical imaging.

Technological Characteristics

DICOM-conformant viewing workstation; supports LAN, WAN, and dial-up connectivity; designed for on-site and off-site image viewing and reporting.

Indications for Use

Indicated for use as a viewing station for patient information, medical images, and reporting in clinical environments via LAN, WAN, or dial-up connections.

Regulatory Classification

Identification

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.

Predicate Devices

• CompuMed PC Teleradiology product
• Dejarnette Teleshare
• Line Imaging WinRad
• SIENET DRC (MagicView workstation)

Submission Summary (Full Text)

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X955708
Attachment J: Glossary

MAR - 1 1996

Attachment J:

510(K) SUMMARY

CompuMed DICOM client
December 5, 1995
CONFIDENTIAL
510(k) Premarket Notification
Page 43

{1}

Attachment J: Glossary

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

## I. GENERAL INFORMATION

**Establishment:**

- **Address:**
CompuMed Inc
1200 No El Dorado Place C300
Tucson AZ 85715

- **Registration Number:**
2029024

- **Contact Person:**
Loren Larsen
Manager, Regulatory Submissions
520-544-0544 FAX [phone]

- **Date of Submission Preparation:**
December 5, 1995

**Device Name:**

- **Trade Name:**
CompuMed DICOM Client

- **Classification:**
No formal classifications have been issued and Communication Systems) or PACS components. For purposes of determining substantial equivalence, they have been considered to be accessories to medical imaging devices.

- **Performance Standards:**
None established under Section 514 of the Food, Drug, and Cosmetic Act

## II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION

- **Device Description and Intended Use:**
This premarket notification covers the LAN and WAN teleradiology concept (transmission), and study information distribution functions.

The CompuMed DICOM client is a viewing station manufactured by CompuMed, Inc. The CompuMed DICOM client is an on-site (LAN) or off-site (WAN or dial up) station for viewing patient information and images and reporting. It supports industry standard information transmission and communication protocols.

- **Technological Characteristics:**
The LAN and WAN (Teleradiology) products described are DICOM conformant. The CompuMed DICOM client is a low-cost viewing workstation for on-site and off-site viewing and reporting.

- **General Safety and Effectiveness Concerns:**
The device labeling contains instructions for use. It includes indications for use and cautions. This information provides for safe and effective use of the device.

- **Substantial Equivalence:**

CompuMed DICOM client
December 5, 1995
510(k) Premarket Notification
Page 44
CONFIDENTIAL

{2}

Attachment J: Glossary

The CompuMed DICOM client addressed in this premarket notification, is substantially equivalent to the following commercially available devices:

- CompuMed PC Teleradiology product
- Dejarnette Teleshare
- Line Imaging WinRad
- SIENET DRC (MagicView workstation)

The CompuMed DICOM client products have the same intended use and similar technical characteristics as the devices listed above.

Signature: Phillip Beccu
Date: 12/12/95

CompuMed DICOM client
December 5, 1995
CONFIDENTIAL
510(k) Premarket Notification
Page 45