(78 days)
ALI UltraPACS (K925965/A)
No
The description explicitly states the use of industry standard JPEG and Motion JPEG lossy compression, with no mention of AI or ML techniques.
No
This device is an accessory to a Picture Archiving and Communication System (PACS) intended for data compression and transmission of diagnostic images. It does not perform any direct therapeutic function or intervention.
No
The device is an accessory for image compression and archiving. It does not perform diagnostic functions itself but helps manage previously acquired diagnostic images.
Yes
The device is described as a "Data Compression Module" and an "accessory" to a PACS system, focusing solely on the software-based process of image compression using JPEG and Motion JPEG. There is no mention of any hardware component being part of this specific device submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for compressing and transmitting digitized diagnostic images. This is related to the handling and management of medical images, not the analysis of biological samples or the diagnosis of diseases based on in vitro tests.
- Device Description: The description confirms that it's a data compression module for a PACS system, using standard image compression techniques.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device deals with the digital representation of medical images, which are acquired through imaging modalities, not through in vitro testing.
N/A
Intended Use / Indications for Use
The ALI comPACS Data Compression Module for Diagnostic Images is an accessory to the ALI UltraPACS (K925965/A) Picture Archiving and Communication System. Through the use of JPEG and Motion JPEG lossy compression, ALI comPACS is intended to provide:
-
- significant reductions in the amount of electronic storage space for digitized diagnostic still images and digitized video of diagnostic images while maintaining medically acceptable diagnostic quality of the images; and
-
- significant reductions in the amount of time to transmit digitized diagnostic still images and digitized video of diagnostic images from storage to viewing sites, while maintaining medically acceptable diagnostic quality of the images.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The ALI comPACS Data Compression Module for Diagnostic Images is an accessory to the ALI UltraPACS (K925965/A) Picture Archiving and Communication System.
ALI comPACS operates as follows:
- The clinical operator selects the functions where lossy compression is to be applied 1. (archiving, viewing, transmitting, still images, videos) .
-
- The clinical operator selects the compression ratio based on medical preference of two images/videos, one the original image/video and the second the image/video compressed to the desired lossy compression ratio.
-
- The clinical operator proceeds with use of ALI UltraPACS. Images/videos that have been lossy compressed have the characters "LOSSY xx:1" (where xx is the compression ratio) placed in the visible, non-diagnostic area of the image or video.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
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.
CEMAX-ICON Archive Manager 2.0 and Autorad modules (K955092)
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.
ALI UltraPACS (K925965/A)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
Summary of Safety and Effectiveness for ALI comPACS Data Compression Module for Diagnostic Images
8.1 Demographic Information
NOV 27 1996
8.1.1 Date Prepared
September 9, 1996
8.1.2 Submitter
A.L.I. Technologies Inc. 95-10551 Shellbridge Way Richmond, B.C. Canada, V6X 2W9 Tel: 604-279-5422 Fax: 604-279-5468
8.1.3 Contact
Robert MacNeil P.Eng. Manager, Quality Assurance and Regulatory Affairs
8.2 Device Name
8.2.1 Trade or Proprietary Name
ALI comPACS Data Compression Module for Diagnostic Images
8.2.2 Common Name
ALI comPACS Data Compression Module for Diagnostic Images
8.2.3 Classification Name
There is no official FDA classification name for this accessory. The common name used by FDA for these devices is Picture Archiving and Communications Systems.
8.3 Devices to which Substantial Equivalence is being Claimed
CEMAX-ICON Archive Manager 2.0 and Autorad modules (K955092).
8.4 Device Description
8.4.1 Function
The ALI comPACS Data Compression Module for Diagnostic Images is an accessory to the ALI UltraPACS (K925965/A) Picture Archiving and Communication System.
ALI comPACS operates as follows:
- The clinical operator selects the functions where lossy compression is to be applied 1. (archiving, viewing, transmitting, still images, videos) .
-
- The clinical operator selects the compression ratio based on medical preference of two images/videos, one the original image/video and the second the image/video compressed to the desired lossy compression ratio.
1
-
- The clinical operator proceeds with use of ALI UltraPACS. Images/videos that have been lossy compressed have the characters "LOSSY xx:1" (where xx is the compression ratio) placed in the visible, non-diagnostic area of the image or video.
8.4.2 Scientific Concept
ALI comPACS uses industry standard JPEG and Motion JPEG lossy compression for the compression of digitized diagnostic still images and digitized video of diagnostic images, respectively. The scientific concept of JPEG compression is defined in the ISO //EC standard ISO/IEC 10918-1 Digital Compression and Coding of Continuous Tone Still Images. Motion JPEG is a file format for the storage of sequentially JPEG compressed frames of video.
8.4.3 Significant Physical and Performance Characteristics
| Compression Method | JPEG Lossy Compression |
|---|---|
| Compression Ratio Range | 4:1 up to 10:1 |
| Original Diagnostic Image | |
| Size (pixels and depth) | Greyscale |
| 640 horizontal x 480 vertical (NTSC), 256 levels (8 bit) | |
| 768 horizontal x 576 vertical (PAL), 256 levels (8 bit) |
Colour
640 horizontal x 480 vertical (NTSC), 16.7 million colours (24 bit)
768 horizontal x 576 vertical (PAL), 16.7 million colours (24 bit) |
| DICOM 3.0 Compliant | Yes |
| Functions where Compression
can be applied | Archiving, Viewing, Transmitting |
For compression of digitized diagnostic still images
For compression of digitized video of diagnostic images
| Compression Method | Motion JPEG Lossy Compression |
|---|---|
| Compression Ratio Range | 4:1 up to 30:1 |
| Compatible Video Signals | Composite Video, S-Video, NTSC, PAL |
| Capture Rate | Up to 30 frames/second (NTSC), |
| 25 frames/second (PAL). | |
| Up to 60 fields/second (NTSC), | |
| 50 fields/second (PAL). | |
| Frame Dimensions (in pixels) | Up to 640 horizontal x 480 vertical (NTSC), |
| Up to 768 horizontal x 576 vertical (PAL) | |
| Colour Depth | YUV 4:2:2, 16.7 million colours (24 bit colour) |
| Maximum Length of Captured Video | 120 seconds |
| Functions where Compression can be applied | Archiving, Viewing, Transmitting |
8.5 Statement of Intended Use
The ALI comPACS Data Compression Module for Diagnostic Images is an accessory to the ALI UltraPACS (K925965/A) Picture Archiving and Communication System. Through the use of JPEG and Motion JPEG lossy compression, ALI comPACS is intended to provide:
-
- significant reductions in the amount of electronic storage space for digitized diagnostic still images and digitized video of diagnostic images while maintaining medically acceptable diagnostic quality of the images; and
2
-
- significant reductions in the amount of time to transmit digitized diagnostic still images and digitized video of diagnostic images from storage to viewing sites, while maintaining medically acceptable diagnostic quality of the images.
8.6 Comparison of Technological Characteristics
The ALI comPACS Data Compression Module for Diagnostic Images is substantially equivalent to the CEMAX-ICON Archive Manager 2.0 and Autorad modules (K955092). Archive Manager 2.0 and Autorad, with its related Telemax software module (for viewing images under Windows 95 or MAC) and Imagecom software modules (for image transmission) use JPEG compression for viewing. transmitting, and archiving images using lossy compression.
| Feature | ALI comPACS | CEMAX-ICON
product |
|------------------------------------------------------------------------------------|-------------|---------------------------------------|
| Uses JPEG lossy compression in viewing images | Yes | Yes (Autorad,
Telemax) |
| Uses JPEG lossy compression in transmitting
images | Yes | Yes (Imagecom) |
| Uses JPEG lossy compression for archiving
images | Yes | Yes (Archive
Manager 2.0) |
| Uses Motion JPEG for viewing digital video of
medical images | Yes | No (limited to still
frame images) |
| Uses Motion JPEG for transmitting digital video of
medical images | Yes | No (limited to still
frame images) |
| Uses Motion JPEG for archiving digital video of
medical images | Yes | No (limited to still
frame images) |
| Compression level bounded | Yes | Yes (fixed value) |
| DICOM 3.0 compliant for still images (DICOM
does not yet address digital video) | Yes | Yes |
The major difference between ALI comPACS and the CEMAX-ICON products Archive Manager 2.0 and Autorad is that ALI comPACS provides viewing, transmission, and archiving of lossy compressed digital video. ALI comPACS uses Motion JPEG for compressing the digital video of the diagnostic images. Motion JPEG is an intraframe JPEG compression format (i.e. JPEG applied to each frame, then each frame is stored), which is essentially a storage format for sequential JPEG compressed images presented at a chosen frame rate. Thus Motion JPEG compression does not raise any additional issues of safety or effectiveness beyond those already addressed by JPEG compression itself.
In conclusion, ALI comPACS is substantially equivalent to the CEMAX-ICON products Archive Manager 2.0 and Autorad.