IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)

K963594 · Dejarnette Research Systems · LMD · Nov 7, 1996 · Radiology

Device Facts

• Record ID: K963594
• Device Name: IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)
• Applicant: Dejarnette Research Systems
• Product Code: LMD · Radiology
• Decision Date: Nov 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The Imageshare Secondary Capture Acquisition Station and/or Software is a uni-directional gateway that receives digital or analog images from various image sources (including, but not limited to, film digitizers, video signal outputs or print output from imaging modalities, or other imaging sources). The incoming data formats are bitmapped, raster images or proprietary to the modality source vendor. The Imageshare Secondary Capture Acquisition Station and/or Software converts the data to DICOM, ACR-NEMA v2.0, SPI format or other proprietary data format and transmits the data to one or more user-specified nodes across a standard, general purpose computing network.

Device Story

Imageshare Secondary Capture Acquisition Station acts as a gateway for medical imaging networks. It accepts digital or analog image inputs from sources like film digitizers, video signals, or modality print outputs. The system reformats these bitmapped or proprietary raster images into standard formats (DICOM, ACR-NEMA v2.0, SPI) and transmits them to specified network nodes. It operates on general-purpose computing hardware, storing data locally until transmission is acknowledged by the destination. If transmission fails or power is lost, the system queues images for retransmission. It is configured by system administrators to suit specific clinical PACS environments. The device facilitates image routing and interoperability between disparate imaging modalities and digital storage/viewing systems, ensuring reliable delivery of diagnostic data.

Clinical Evidence

Bench testing only.

Technological Characteristics

Runs on off-the-shelf, general-purpose computing hardware. Functions as a software-based gateway for image format conversion (bitmapped/raster to DICOM, ACR-NEMA v2.0, SPI). Connectivity via standard general-purpose computing networks. Designed for portability across operating systems.

Regulatory Classification

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.

Predicate Devices

• Imageshare 910™
• Imaging Workbench™ (BRIT Systems, Inc.)
• FISSTM (Star Technologies, Inc.)
• RadWorks™ (Applicare Medical Imaging B.V.)

Submission Summary (Full Text)

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DEJARNETTE 510(k) Notification — Premarket Submission

1. 510(k) Summary
K963594
NOV - 7 1996

510(k) Summary
[As required by 21 CFR 807.92(c)]

1.0 Submitter Information
1.1 DeJarnette Research Systems
401 Washington Avenue Suite 700
Towson MD 21204
1.2 Contact: Wayne T. DeJarnette, Ph.D.
Voice: +1 (410) 583 - 0680
Fax: [phone] - 0696
E-mail: [e-mail]
1.3 Date Prepared: 6 Sept 1996

2.0 Device Identification
2.1 Trade Name: Imageshare Secondary Capture Acquisition Station and/or Software
2.2 Common Name: Gateway to Digital Imaging Network
2.3 Classification Name: System, Digital Image Communication, accessory

3.0 Predicate Devices
Imageshare 910™ (DeJarnette Research Systems, Inc.)
Imaging Workbench™ (BRIT Systems, Inc.)
FISSTM (Star Technologies, Inc.)
RadWorks™ (Applicare Medical Imaging B.V.)

4.0 Device Description
4.1 Function:
The Imageshare Secondary Capture Acquisition Station is a general purpose computer system running an image acquisition software application to receive, reformat and transmit image and demographic information. The system receives the image messages from a source (film digitizer, video source, ultrasound, print output, etc.) and routes them automatically through a conversion to a destination based on information contained in the message source, encoded data and data entered by an operator through a user interface. The Imageshare Secondary Capture Acquisition Station stores the data on its local hard disk until the destination application acknowledges the successful transmission. Images not delivered to their destination are queued for retransmission until the remote destination confirms receipt of the message. Image delivery is also guaranteed when the Imageshare Secondary Capture Acquisition Station loses power and is restarted.

The Imageshare Secondary Capture Acquisition Station is adaptable to various PACS environments. The configuration can be modified by the system administrator to adapt the Imageshare Secondary Capture Acquisition Station to perform functions specific to the site.

401 Washington Avenue, Suite 700
[DRS-KQ0002-xxx]
Towson, Maryland 21204
Tel.: [phone] Fax: [phone]
Page 1-1

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DEJARNETTE 510(k) Notification — Premarket Submission

## 4.2 Physical and Performance Characteristics:

The Imageshare Secondary Capture Acquisition Station and/or Software is designed to run on off-the-shelf, general purpose computing equipment. The application software is designed for maximum portability across operating systems and hardware platforms. Performance of the application software is primarily a function of network load; secondarily a function of the hardware platform’s computational speed, and finally the limitation of the image capture device. Intrinsic performance of the application does not change significantly as it is ported from one operating system to another.

## 5.0 Intended Use:

The Imageshare Secondary Capture Acquisition Station and/or Software is a uni-directional gateway that receives digital or analog images from various image sources (including, but not limited to, film digitizers, video signal outputs or print output from imaging modalities, or other imaging sources). The incoming data formats are bitmapped, raster images or proprietary to the modality source vendor. The Imageshare Secondary Capture Acquisition Station and/or Software converts the data to DICOM, ACR-NEMA v2.0, SPI format or other proprietary data format and transmits the data to one or more user-specified nodes across a standard, general purpose computing network.

## 6.0 Statement of Substantial Equivalence:

The Imageshare Secondary Capture Acquisition Station and/or Software is substantially equivalent to previously marketed devices (as listed above in Part 3) in design, composition, function, intended use, safety and efficacy.

Any differences between the Imageshare Secondary Capture Acquisition Station and/or Software and the predicate devices have no significant influence on safety or efficacy. No new issues of safety and effectiveness are raised.

401 Washington Avenue, Suite 700
Towson, Maryland 21204
Tel.: [phone] Fax: [phone]
[DRS-KQ0002-xxx] Page 1-2