FREEPIX/PIXPACS DICOM/HTTP GATEWAY

K970174 · Pixelinks, Inc. · LMD · May 1, 1997 · Radiology

Device Facts

• Record ID: K970174
• Device Name: FREEPIX/PIXPACS DICOM/HTTP GATEWAY
• Applicant: Pixelinks, Inc.
• Product Code: LMD · Radiology
• Decision Date: May 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

to allow standard Web Browsers or DICOM devices, connected via LAN or WAN, to access and view DICOM images stored on a central DICOM 3.0 archive

Device Story

FreePix is a standalone gateway/server system connecting DICOM 3.0 archives to TCP/IP networks. It performs protocol conversion between DICOM 3.0 and HTTP/HTML, enabling standard web browsers to access and display medical images. The system utilizes an IBM-compatible PC running Linux/UNIX, an off-the-shelf web server (httpd), an SQL-based relational database, and the Mallinckrodt Institute of Radiology (MIR) DICOM 3.0 server. Proprietary CGI programs interface web clients to the database. Used in clinical environments to facilitate image viewing; does not perform image post-processing. Benefits include expanded accessibility to diagnostic images across various computer platforms (PC, Mac, UNIX) without requiring proprietary viewing software.

Clinical Evidence

Bench testing only. Performance verified using a standard set of DICOM images from multiple modalities. Testing involved 'push' operations via DICOM C-Store to the local archive and subsequent retrieval for viewing via web browsers. Success defined by the absence of errors during data transfer and retrieval phases.

Technological Characteristics

Hardware: IBM-compatible PC (Pentium Pro 200 MHz, 32 MB RAM, 2-9 GB HDD). OS: Linux/UNIX 2.x. Software: Off-the-shelf httpd web server, SQL relational database, MIR-based DICOM 3.0 server. Connectivity: TCP/IP Ethernet LAN/WAN. Function: Protocol conversion (DICOM to HTTP/HTML).

Indications for Use

Indicated for clinicians and healthcare personnel requiring remote or local access to DICOM 3.0 medical images via standard web browsers on networked computers.

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

• GE CT HiLight with independent remote viewing station (K970174)

Submission Summary (Full Text)

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FreePix DICOM/HTTP Gateway
MAY - 1 1997
510(k) Summary
K970174

# FreePix DICOM/HTTP Gateway - 510(k) Summary Information

The FreePix/PixPACS ('FreePix') is a standalone gateway/server system, connected to a TCP/IP network. It performs transparent online protocol and format conversion between the DICOM 3.0 protocol/format and the HTTP/HTML protocol/format. The FreePix enables any HTTP/HTML compliant Web Browser, running on any computer platform (e.g. PC, Macintosh, UNIX), to access and display image and archive data obtained from DICOM 3.0 compliant systems connected on the same network.

The Intended Use of this device is "to allow standard Web Browsers or DICOM devices, connected via LAN or WAN, to access and view DICOM images stored on a central DICOM 3.0 archive".

The FreePix system normally consists of a standard IBM-compatible PC (e.g. Pentium Pro 200 MHz CPU with 32 MB RAM, 2 GB HDD, optional 9 GB HDD), using off-the-shelf components, running the Linux/UNIX 2.x OS (operating system).

In addition to the basic OS, the FreePix configuration consists of an off-the-shelf Web Server package (httpd), an off-the-shelf SQL-based relational database engine and the Mallinckrodt Institute of Radiology (MIR) based DICOM 3.0 server.

The proprietary software of the FreePix consists of relatively small DICOM-to-Web CGI programs which interface the Web clients to the database engine via the MIR based DICOM package, as well as a set of user configuration and authentication utilities to enforce customizable access control.

Note that the off-the-shelf Web Browsers (and/or the computers they run on) needed to actually view images are not manufactured by PixeLinks and are not part of this submission.

The FreePix server system is tested prior to use by utilizing a standard set of test data, i.e. DICOM images from multiple modalities obtained from various medical imaging manufacturers. This data set, maintained on a CD-ROM, is sent to the FreePix via a DICOM C-Store ('push') operation on the TCP/IP LAN, is stored by the FreePix on its local archive, and is subsequently retrieved for viewing by LAN based Web Browsers. Any error whatsoever, encountered during the data push or retrieve phases, indicates a fault which must be identified and corrected prior to actual use. These tests can be conveniently re-performed at any stage during product development, manufacturing, installation and post-installation maintenance to verify the proper performance of the hardware and software of the FreePix.

Virtually all modern, LAN based, medical imaging clinics can be selected as predicate devices for the FreePix and its related (but not submitted) client systems. As a typical

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K970174

FreePix DICOM/HTTP Gateway

510(k) Summary

example, we selected the configuration of the GE CT HiLight with an independent remote viewing station (when used for viewing and not post-processing).

Table - Comparison between FreePix and SE Device

| Feature | CT HiLight + Viewing | FreePix + Web Browsers |
| --- | --- | --- |
| LAN | TCP/IP, Ethernet | TCP/IP, Ethernet |
| Protocol | GE, DICOM 3.0 | DICOM 3.0, HTTP |
| Catalogs | Patient, Study, Series, Image | Patient, Study, Series, Image |
| Image Depth (in bits) | Raw image 16, display 8 | Raw image 16 (max), display 8 |
| Windowing | Local at Viewing Station | performed by FreePix server |
| Processing | Yes | viewing only |
| Image size (max) | 1024x1024 special mode
512x512 standard mode | 512x512, 1024x1024 or other |
| Local Storage | Yes | Yes |

Based on the above comparison, it is our opinion that in terms of safety and effectiveness, the configuration of the FreePix gateway/server coupled with the DICOM 3.0 data source and HTTP/HTML viewing station on a TCP/IP LAN is substantially equivalent to the configuration when viewing (non-processing) is performed on an independent viewing station coupled with the scanner of the predicate device, or generically viewing patient or image data using the standard viewing stations attached to the existing digital imaging modalities.

## Contact Information:

PixeLinks Inc, Attention: S. Beer

35 Airport Rd., Suite 310, Morristown, NJ 07960, Tel: [phone]

Device Name(s): FreePix DICOM to HTTP Gateway, PixPACS

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