LINX NETWORKING SYSTEM

K964250 · Sterling Diagnostic Imaging, Inc. · LMD · Dec 18, 1996 · Radiology

Device Facts

• Record ID: K964250
• Device Name: LINX NETWORKING SYSTEM
• Applicant: Sterling Diagnostic Imaging, Inc.
• Product Code: LMD · Radiology
• Decision Date: Dec 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1

Intended Use

The basic product concept remains - to connect various image input devices to one or more output devices.

Device Story

LINX Networking System connects diverse medical image input devices (e.g., tubes, digitizers, computed radiography) to multiple output devices (e.g., laser imagers, teleradiology systems, DICOM devices). System manages image, text, and patient data. Operates via network interfaces (Ethernet, ATM, FDDI) and protocols (TCP/IP, QNX). Supports image processing functions including cropping, LUT application, sharpness filtering, interpolation, decimation, and lossless compression. Used by clinical staff to facilitate image transfer and management across LAN/WAN environments. Enhances workflow by enabling centralized control and distribution of diagnostic data to various output destinations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Network-based image management system. Interfaces: tubes (up to 160Mhz pixel clock), digital 485427, digitizer, computed radiography, removable media, DICOM. Network: Token-ring, Ethernet, ATM, FDDI. Protocols: QNX, TCP/IP. Image processing: LUT, sharpness filter, interpolation, decimation, lossless compression. Operator interfaces: hardware keypad, Windows, remote host. Accessory interfaces: densitometer, bar code entry.

Indications for Use

Indicated for the networking and management of medical diagnostic images, text, and patient information across various input and output devices in a clinical environment.

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

• LINX™ Networking System with LINX™ Laser Imager (K900935)

Submission Summary (Full Text)

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DEC 18 1996
K9604250
STERLING
Diagnostic Imaging, Inc.

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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.

SUBMITTED BY:

Jean E. Bartlett
[phone]
Regulatory Affairs
Sterling Diagnostic Imaging, Inc.
Glasgow Business Community
Building 600/Mailbox 630
Newark, DE 19714-6101
Fax # [phone]

DEVICE NAME:

LINX™ Networking System

PREDICATE DEVICE:

LINX™ Networking System with LINX™ Laser Imager (K900935)

DEVICE DESCRIPTION AND INTENDED USE:

This Premarket Notification 510(k) is being filed to cover additions to the LINX™ Networking System with LINX™ Laser Imager (K900935) to include all capabilities that we are adding to meet market demands. The basic product concept remains - to connect various image input devices to one or more output devices. That basic concept has been expanded to meet market demands:

- new image source interfaces
- new control interfaces
- new network interfaces
- more output devices supported
- new data types managed
- image transfer mechanisms
(some output devices may require handling in the transmission path to the output device to compensate for differences in devices)

Glasgow Business Community
P.O. Box 6101
Building 600, Mailstop 630
Newark, DE 19714-6101

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DEVICE COMPARISON TO PREDICATE DEVICE:

The LINX™ Networking System is substantially equivalent to the LINX™ Networking System with LINX™ Laser Imager (K900935) as summarized below:

| Characteristic | LINX Networking System | LINX Networking System (Expanded) |
| --- | --- | --- |
| Image Sources | | |
| tubes | X (up to 45Mhz pixel clock speed) | X (up to 160Mhz pixel clock speed) |
| digital 485427 | X | X |
| digitizer interface | | X |
| computed radiography int | | X |
| removable media | | X |
| network interfaces | | X |
| DICOM Devices | | X |
| Network connections | | |
| token - ring | X | X |
| ethernet | | X |
| ATM | | X |
| FDDI | | X |
| protocols | | |
| QNX | X | X |
| TCP/IP | | X |
| Interface methods | | |
| point - point | X | X |
| network | X | X |
| LAN | X | X |
| WAN | | X |
| Operator Interfaces | | |
| hardware keypad | X | X |
| Windows | | X |
| remote host | | X |
| Data Types | | |
| image | X | X |
| text | X | X |
| patient info | | X |
| Output devices | | |
| LINX Laser Imager | X | X |
| 3M 952 | X | X |
| 3M 831 | X | X |
| 3M 969 | X | X |
| LP400 | X | X |
| home telerad systems | | X |
| DICOM Devices | | X |
| File systems | | X |

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| Characteristic | LINK Networking System | LINK Networking System (Expected) |
| --- | --- | --- |
| Accessory Device Interfaces | | X |
| Densitometer | | X |
| Bar Code Entry | | X |
| Statistics Recording | X | X |
| Image Data | | X |
| Service Data | X | X |
| Image transfer mechanisms | | |
| straight thru | X | X |
| crop | | X |
| LUT | X | X |
| sharpness filter | | X |
| interpolate | | X |
| decimate | | X |
| compress (lossless) | | X |