(111 days)
Not Found
No
The device description focuses on protocol and format conversion for image viewing, and there is no mention of AI, ML, or related concepts in the provided text.
No
The device is described as a gateway/server system for viewing DICOM images, not for treating or diagnosing medical conditions.
No
The device is described as a standalone gateway/server system that allows standard Web Browsers or DICOM devices to access and view DICOM images stored on a central archive. It performs protocol and format conversion for viewing images, but it does not specify any diagnostic capabilities or analysis.
No
The device is described as a "standalone gateway/server system" which implies it includes hardware components beyond just software. While its primary function is software-based protocol conversion and image display, the description of it as a "system" and its connection to a network suggests it is not purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide access and viewing of DICOM images stored on an archive. This is a data management and display function, not a diagnostic test performed on biological samples.
- Device Description: The device acts as a gateway/server for protocol and format conversion between DICOM and HTTP/HTML. It facilitates access and display of existing medical images.
- No mention of biological samples: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with biological samples.
- Focus on image access and display: The core function is to make medical images accessible and viewable through standard web browsers.
While the device handles medical images which are used in the diagnostic process, the device itself is a tool for managing and displaying that data, not for performing a diagnostic test on a biological sample.
N/A
Intended Use / Indications for 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".
Product codes
Not Found
Device Description
The FreePix/PixPACS ('FreePix') is a standalone gateway/server system, connected to a The I roll in I m Free masparent 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 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-theshelf 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM images from multiple modalities
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2020 Medical image communications device.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
FreePix DICOM/HTTP Gateway
510(k) Summary
FreePix DICOM/HTTP Gateway - 510(k) Summary Information
The FreePix/PixPACS ('FreePix') is a standalone gateway/server system, connected to a The I roll in I m Free masparent 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-theshelf 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
1
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).
| 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, 1024x1024 or other |
| 512x512 standard mode | ||
| Local Storage | Yes | Yes |
Table - Comparison between FreePix and SE Device
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: 1-201-267-2341
Device Name(s): FreePix DICOM to HTTP Gateway, PixPACS