(80 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware and basic image handling software.
No
The device is described as an "Aurora Diagnostic Workstation" and an "Aurora Medical Imaging Workstation" used for retrieving and displaying medical images, indicating a diagnostic rather than therapeutic purpose.
Yes
The device explicitly states "The intended use of the Aurora Diagnostic Workstation is identical to other commercially available medical imaging workstations," and "Diagnostic Workstation" implies a diagnostic purpose.
No
The device description explicitly lists hardware components such as a personal computer, processor board set, CRT monitors, and video controller boards, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as "identical to other commercially available medical imaging workstations." Medical imaging workstations are used for viewing and manipulating medical images, not for performing tests on biological samples.
- Device Description: The components listed (personal computer, processor board, monitors, video controller boards, software) are typical for an imaging workstation. There is no mention of reagents, assays, or equipment designed to analyze biological specimens.
- Lack of IVD Characteristics: The description does not include any elements associated with IVD devices, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis based on laboratory test results
The device is clearly described as a system for handling and displaying medical images, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the Aurora Diagnostic Workstation is identical to other commercially available medical imaging workstations.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
N/A
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
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
[As required by 21 CFR 807.92(a)]
Submitter Information A.
Submitter's Name:
Aurora Technology
Address:
Telephone Number: Fax Number: Contact Person: Submission Preparation Date:
10560 Wayzata Blvd. Minneapolis, MN 55305 612/ 593-9960 612/ 593-9819 C. Paul Pesek, President June 28, 1996
SEP 2 0 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. |
1
Comparison of Required Technological Characteristics C.
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.