AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES

K963610 · A.L.I. Technologies, Inc. · LLZ · Nov 27, 1996 · Radiology

Device Facts

• Record ID: K963610
• Device Name: AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES
• Applicant: A.L.I. Technologies, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

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: 1. 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.

Device Story

The ALI comPACS Data Compression Module is an accessory to the ALI UltraPACS system. It accepts digitized diagnostic still images and video as input. The device applies industry-standard JPEG (for still images) and Motion JPEG (for video) lossy compression algorithms to reduce file size for archiving, viewing, and transmission. The clinical operator selects the compression ratio based on visual comparison of original and compressed images. Compressed files are marked with a 'LOSSY xx:1' indicator in a non-diagnostic area. The device is used by clinical operators within a PACS workflow to optimize storage space and transmission speed. The healthcare provider views the compressed images to make clinical decisions, relying on the system's maintenance of medically acceptable diagnostic quality.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and the use of industry-standard JPEG/Motion JPEG compression algorithms.

Technological Characteristics

Accessory software module for PACS. Utilizes industry-standard JPEG (ISO/IEC 10918-1) for still images and Motion JPEG for video. Supports compression ratios of 4:1 to 10:1 for stills and 4:1 to 30:1 for video. DICOM 3.0 compliant for still images. Compatible with NTSC/PAL composite and S-Video signals. Operates as an integrated component of the ALI UltraPACS system.

Indications for Use

Indicated for clinical operators requiring storage and transmission of digitized diagnostic still images and video within a Picture Archiving and Communication System (PACS) environment.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• CEMAX-ICON Archive Manager 2.0 and Autorad modules (K955092)

Reference Devices

• ALI UltraPACS (K925965/A)

Submission Summary (Full Text)

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510(k) Summary
K9636/0

# 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: [phone]
Fax: [phone]

### 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:

1. The clinical operator selects the functions where lossy compression is to be applied (archiving, viewing, transmitting, still images, videos).
2. 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.

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3. 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/IEC 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

For compression of digitized diagnostic still images

| 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 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:

1. 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

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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.

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