IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE

K963628 · Dejarnette Research Systems · LMD · Nov 7, 1996 · Radiology

Device Facts

• Record ID: K963628
• Device Name: IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
• 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 Computed Radiography Acquisition Station and/or Software is a uni-directional gateway that receives digital images from various image sources (including, but not limited to, Fuji CR, Fuji HI-C654, Analogic Corporation’s DASM, Computed Radiography or Direct Radiography devices). The incoming data formats may be raw CR data, processed CR data or data formats proprietary to the modality source vendor. The Imageshare Computed Radiography 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

Device functions as uni-directional gateway for digital medical images; receives raw/processed CR or proprietary modality data; reformats data into DICOM, ACR-NEMA v2.0, or SPI formats; transmits data across standard networks to user-specified nodes. Operates on off-the-shelf general purpose computing hardware. Used in clinical environments to facilitate image routing and network communication between imaging modalities and destination applications. System stores data locally on hard disk until transmission acknowledgment; includes power-loss recovery mechanism. Benefits include automated image routing and interoperability between disparate imaging systems.

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 proprietary modality formats and standard formats (DICOM, ACR-NEMA v2.0, SPI). Network-based connectivity. Performance dependent on network load and hardware computational speed.

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
• Fuji Computed Radiography DMS CRT Image Console HI-C654™
• CEMAX ScanLink IV™ QA Station
• Analogic SD100 CR Gateway

Submission Summary (Full Text)

{0}

DEJARNETTE 510(k) Notification — Premarket Submission

# 1. 510(k) Summary

NOV - 7 1996
K963628

## 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: 9 Sept 1996

## 2.0 Device Identification

### 2.1 Trade Name: Imageshare Computed Radiography 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
Fuji Computed Radiography DMS CRT Image Console HI-C654™
CEMAX ScanLink IV™ QA Station
Analogic SD100 CR Gateway

## 4.0 Device Description

### 4.1 Function:

The Imageshare Computed Radiography Acquisition Station and/or Software is designed to operate on 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 Computed Radiography or other image source and routes them automatically through a conversion to a destination based on information contained in the message source, encoded data or data entered by an operator through a user interface. The Imageshare Computed Radiography Acquisition Station stores the data on its local hard disk until the destination application acknowledges the successful transmission. Image delivery is also guaranteed when the Imageshare Computed Radiography Acquisition Station loses power and is restarted.

### 4.2 Physical and Performance Characteristics:

The Imageshare Computed Radiography 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. Intrinsic performance of the application does not change significantly as it is ported from one operating system to another.

401 Washington Avenue, Suite 700
Towson, Maryland 21204
Tel.: [phone] Fax: [phone]
[DRS-KQ0004-xxx] Page 1-1

{1}

DEJARNETTE 510(k) Notification — Premarket Submission

## 5.0 Intended Use:

The Imageshare Computed Radiography Acquisition Station and/or Software is a uni-directional gateway that receives digital images from various image sources (including, but not limited to, Fuji CR, Fuji HI-C654, Analogic Corporation’s DASM, Computed Radiography or Direct Radiography devices). The incoming data formats may be raw CR data, processed CR data or data formats proprietary to the modality source vendor. The Imageshare Computed Radiography 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 Computed Radiography 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. No new issues of safety and effectiveness are raised.

Any differences between the Imageshare Computed Radiography Acquisition Station 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-KQ0004-xxx] Page 1-2