AURORA DIAGNOSTIC WORKSTATION

K962589 · Aurora Technology, Inc. · LLZ · Sep 20, 1996 · Radiology

Device Facts

• Record ID: K962589
• Device Name: AURORA DIAGNOSTIC WORKSTATION
• Applicant: Aurora Technology, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The intended use of the Aurora Diagnostic Workstation is identical to other commercially available medical imaging workstations.

Device Story

Aurora Diagnostic Workstation; PC-based medical imaging workstation for PACS. Inputs: stored medical images. Processing: proprietary processor board for decompression of tiled images; video controller boards for display management. Outputs: high-resolution (1024 x 1280) monochrome CRT monitor visualization. Used in clinical settings by healthcare professionals for image retrieval, handling, and viewing. Facilitates diagnostic review of medical images; supports clinical decision-making by providing access to archived imaging data.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence based on comparison of design, function, and performance characteristics to predicate devices.

Technological Characteristics

PC-based workstation; up to eight 1024 x 1280 monochrome CRT monitors; proprietary processor board for image decompression; proprietary video controller boards; proprietary software for retrieval and user interface.

Indications for Use

Indicated for use as a medical imaging workstation for the retrieval and viewing of medical images in a clinical 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

• Eltrax Systems, Inc. (now Emerald Archiving, Inc.) user retrieval and image viewing stations

Submission Summary (Full Text)

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SEP 20 1996
K962589

510(k) SUMMARY

[As required by 21 CFR 807.92(a)]

A. Submitter Information

Submitter’s Name: Aurora Technology

Address: 10560 Wayzata Blvd.
Minneapolis, MN 55305

Telephone Number: 612/593-9960
Fax Number: 612/593-9819
Contact Person: C. Paul Pesek, President
Submission Preparation Date: June 28, 1996

B. Device Information

Trade Name: Aurora™ Diagnostic Workstation.

Common Name: Medical Imaging Workstation, a component of picture archiving and communications systems (PACS).

Classification Name: No formal classifications have been issued for PACS or PACS components. For purposes of determining substantial equivalence, they have been considered to be accessories to medical imaging devices.

Predicate Device: Aurora Technology believes that the Aurora workstation components are substantially equivalent to other commercially available medical image displays, specifically, the user retrieval and image viewing stations manufactured by Eltrax Systems, Inc. (now Emerald Archiving, Inc.).

Device Description: The Aurora Medical Imaging Workstation consists of a personal computer, a “Processor” board set for decompression of tiled, stored images; up to eight high resolution (1024 x 1280) monochrome CRT monitors; up to eight video controller boards to display and store the image; a retrieval monitor; and proprietary software for retrieval, image handling and the user interface.

Intended Use: The intended use of the Aurora Diagnostic Workstation is identical to other commercially available medical imaging workstations.

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C. Comparison of Required Technological Characteristics

Aurora Technology considers the Aurora diagnostic imaging workstation to be substantially equivalent in device design, function, and intended use to user retrieval and image viewing stations manufactured by Eltrax Systems, Inc. (now called Emerald Archiving, Inc.) and other commercially available medical image displays.

| Characteristics | Aurora Medical Imaging Workstation |
| --- | --- |
| a. Product Labeling | Substantially equivalent |
| b. Intended Use | Identical |
| c. Physical Characteristics | Substantially equivalent |
| d. Anatomical Sites | N/A |
| e. Target Population | Identical |
| f. Performance Testing | Substantially equivalent |
| g. Safety Characteristics | Substantially equivalent |

D. Summary of Nonclinical Tests

The devices used in the Aurora workstations are not new or significantly improved devices. Except for proprietary processor and video controller board and related software, all components are commercially available.