IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000

K963592 · Dejarnette Research Systems · LMD · Nov 7, 1996 · Radiology

Device Facts

• Record ID: K963592
• Device Name: IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000
• 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 Protocol Converting Gateway and/or Software is a uni-directional (or optionally, bi-directional) gateway that receives digital images from various image sources (including, but not limited to, CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices, imaging gateways, or other imaging sources). The incoming data formats are DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Imageshare Protocol Converting Gateway converts them into DICOM, ACR-NEMA v2.0, SPI format or proprietary data format and transmits the data to one or more user-specified nodes across a standard, general purpose computing network.

Device Story

Imageshare Protocol Converting Gateway is a software-based system running on general-purpose computing hardware. It acts as a gateway to receive, reformat, and transmit digital medical images and demographic data between various imaging modalities (CT, MR, Ultrasound, R/F, CR/DR) and destination nodes (PACS). Input data formats include DICOM, ACR-NEMA v2.0, SPI, or proprietary vendor formats. The system automatically routes and converts these inputs into target formats (DICOM, ACR-NEMA v2.0, SPI, or proprietary) based on administrator-defined configurations. It operates without user interaction, utilizing local hard disk storage to queue images until successful transmission is acknowledged by the destination. The device facilitates interoperability within PACS environments by bridging disparate imaging protocols.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based gateway running on off-the-shelf, general-purpose computing hardware. Supports conversion between DICOM, ACR-NEMA v2.0, SPI, and proprietary imaging protocols. Operates over standard general-purpose computing networks. Designed for portability across operating systems and hardware platforms.

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 (DeJarnette Research Systems, Inc.)
• Merge MVP (Merge Technologies, Inc.)

Submission Summary (Full Text)

{0}

DEJARNETTE 510(k) Notification — Premarket Submission

# NOV - 7 1996

## 1. 510(k) Summary

**K963592**

## 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 September 1996

## 2.0 Device Identification

### 2.1 Trade Name: Imageshare Protocol Converting Gateway 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.)
Merge MVP (Merge Technologies, Inc.)

## 4.0 Device Description

### 4.1 Function:

The Imageshare Protocol Converting Gateway is a general purpose computer system running a protocol conversion software application that uses defined configuration to receive, reformat and transmit image and demographic information. The system receives the image messages from a source and routes them automatically them through a conversion to a remote destination based on information contained in both the message source and encoded data. The system requires no user interaction when in operation. The Imageshare Protocol Converting Gateway stores the image data on its local hard disk until the destination application acknowledges the successful transmission. Images that are not delivered to their destination are queued for retransmission until the remote destination confirms receiving the message. This is also true when the Imageshare Protocol Converting Gateway loses power and is restarted.

The Imageshare Protocol Converting Gateway is adaptable to various PACS environments. The configuration can be modified by the system administrator to adapt the Imageshare Protocol Converting Gateway to perform the desired supported conversions.

401 Washington Avenue, Suite 700
Towson, Maryland 21204
Tel.: [phone] Fax: [phone]
[DRS-KQ0001-xxx] Page 1-1

{1}

DEJARNETTE 510(k) Notification — Premarket Submission

## 4.2 Physical and Performance Characteristics:

The Imageshare Protocol Converting Gateway 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. 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 Protocol Converting Gateway and/or Software is a uni-directional (or optionally, bi-directional) gateway that receives digital images from various image sources (including, but not limited to, CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices, imaging gateways, or other imaging sources). The incoming data formats are DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Imageshare Protocol Converting Gateway converts them into DICOM, ACR-NEMA v2.0, SPI format or 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 Protocol Converting Gateway 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 Protocol Converting Gateway and/or Software and the predicate devices have no significant influence on safety or efficacy.

401 Washington Avenue, Suite 700
Towson, Maryland 21204
Tel.: [phone] Fax: [phone]
[DRS-KQ0001-xxx] Page 1-2