RADWORKS MEDICAL IMAGING SOFTWARE

K962699 · Applicare Medical Imaging, B.V. · LMD · Aug 19, 1996 · Radiology

Device Facts

• Record ID: K962699
• Device Name: RADWORKS MEDICAL IMAGING SOFTWARE
• Applicant: Applicare Medical Imaging, B.V.
• Product Code: LMD · Radiology
• Decision Date: Aug 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The RadWorks™ Medical Imaging Software is a medical device, and it has the same indications for use and target population as the legally marketed predicate devices.

Device Story

RadWorks™ is a stand-alone medical imaging software suite operating on Windows NT™ workstations. It ingests digital images from CT, MRI, CR, US, and video sources (via frame grabbers, digitizers, or network interfaces). The software enables radiologists to view, process, and manage these images. Core features include interactive windowing, zooming, edge enhancement, grey scale inversion, cine loops, annotation, and quantitative measurements (pixel values, angles, distances, histograms). It supports teleradiology via network, ISDN, T1, ATM, or satellite links. Additional modules provide Multi Planar Reconstruction (MPR), Maximum Intensity Projection (MIP), and DICOM 3.0 printing. The system facilitates clinical decision-making by allowing multi-modality image review and comparison of studies. It benefits patients by enabling efficient remote diagnostic review and integration of diverse imaging data into a single workstation environment.

Clinical Evidence

Bench testing only. The device underwent testing according to a Software Test Plan as part of the manufacturer's Software Quality Handbook process.

Technological Characteristics

Stand-alone software running on Windows NT™ OS; hardware-independent (requires minimum specs). Supports DICOM 3.0, ACR-NEMA 1.0/2.0, and proprietary formats. Features include interactive windowing, zoom, edge enhancement, cine loops, and measurement tools. Connectivity via network, ISDN, T1, ATM, or satellite. Supports lossless and JPEG compression.

Indications for Use

Indicated for use by radiologists and medical specialists to view, retrieve, store, process, and transmit medical images from CT, MRI, CR, US, and video sources for diagnostic purposes.

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

• ICON Teleradiology System (K911752)
• Images-on-Call Teleradiology System (K896095)

Submission Summary (Full Text)

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AUG 19 1996

510(k) Premarket Notification

5 July, 1996

K962699

# 510(k) Summary

## RADWORKS™ MEDICAL IMAGING SOFTWARE

Common/Classification Name: Digital Image Communications System

Applicare Medical Imaging B.V.
P.O.Box 416
2400 AK Alphen aan den Rijn
The Netherlands
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

Contact: Ruud Kroon
Prepared: July 5, 1996

## A. LEGALLY MARKETED PREDICATE DEVICES

The RadWorks™ Medical Imaging Software is substantially equivalent to the ICON Teleradiology System by ICON Medical Systems (K911752), and the Images-on-Call Teleradiology System by Devices and Services Company (K896095).

## B. DEVICE DESCRIPTION

Section II of this submission contains a detailed description of the RadWorks™ Medical Imaging Software. The present section is intended as a summary. RadWorks™ is a stand-alone software product.

### Introduction

The RadWorks™ medical imaging software consists of a basic module, RadWorks™ Review, and a number of optional modules, to enable the radiologist to view, retrieve, store, import process and transmit medical images. The RadWorks™ software is an open system which runs under the Microsoft® Windows NT™ operating system and it can operate on any hardware platform which meets the minimum hardware requirements and which supports the Windows NT™ operating system. Windows NT™ based workstations can be made part of UNIX, Novell NetWare, or other networks from major vendors. RadWorks™ is a stand-alone software product and involves no hardware except (optionally) a special graphics card. The minimum hardware configuration is discussed in Section II.

### The basic component: RadWorks™ Review

RadWorks™ Review can display any digital monochrome image from CT, MRI, CR and US. Its built in colour option (using auto detect) also enables the display of 24-bit true colour images. This turns any RadWorks™ system into a true multi-modality workstation that can handle images not only from the Radiology department, but also from Endoscopy, Gastroscopy and other colour (video) sources.

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In monochrome mode, RadWorks™ Review offers features that are used routinely by radiologists and other medical specialists:

- Interactive windowing and an unlimited number of user definable pre-set window level buttons.
- Zooming up to 4 times using fixed settings or flexible zooming using a magnifying glass.
- A 'magic glass' with filtering and edge enhancement.
- A grey scale invert option.
- Interactive panning of zoomed images.
- Adjustable (multiple) cine loops for multiple image series.
- Annotation using markers and text.
- Measurement of pixel values, angles and distances.
- Histograms of pixel distribution along given lines and statistics of flexible regions of interest (ROIs).
- Fully configurable layout of viewports, toolbar positioning and a report option for text comments. In colour mode, the images can be zoomed and panned.

## Connections to the outside world

RadWorks™ can obtain data from various sources. Video images can be frame grabbed, using the Frame Grabber Module. Non DICOM 3.0 digital signals (ACR-NEMA 1.0 or 2.0 or proprietary) can be converted using Conversion Modules. Existing film and accompanying documents can be digitized and scanned using the Digitizer Module and the Document Scanning Module. Information from sources outside the hospital or from other departments can be received using (transparent) teleradiology over the hospital network, using conventional telephone lines, ISDN, T1 and ATM lines or satellite communications. In a departmental network or PACS any RadWorks™ station can open views on DICOM 3.0 compliant archives or other DICOM 3.0 compliant or RadWorks™ viewing stations and perform query and retrieve actions.

## The other RadWorks™ modules

In addition to the basic viewing by RadWorks™ Review and the acquisition modules (Frame Grabbing, Digitizing/Document Scanning and Conversion), the RadWorks™ product line has many other modules available.

The Teleradiology Module provides high quality digital images in a well controlled and protected process. Teleradiology send and receive are taking place in the background, thus allowing for the continuation of viewing and reporting. Lossless compression is available, but also industry standard (DICOM) JPEG compression.

The MPR/MIP module offers high speed Multi Planar Reconstruction and Maximum Intensity Projection.

The Study Compare option allows for opening various studies simultaneously for comparison.

The Print Module supports DICOM 3.0 printing, export to TIFF/BMP files and laser printing.

## C. INTENDED USE

The RadWorks™ Medical Imaging Software is a medical device, and it has the same indications for use and target population as the legally marketed predicate devices.

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# D. TECHNOLOGICAL CHARACTERISTICS

Both the RadWorks™ Medical Imaging Software and the ICON Teleradiology System are stand-alone software packages which can be used on more than one hardware platform. As long as minimum hardware requirements are met, the user is free to choose his/her own hardware platform.

All three systems can transmit to remote viewing stations over phone lines or networks. The RadWorks™ Lite remote software operates on a compatible PC in a receive only mode - it does not transmit. Two regular RadWorks™ systems can send and receive images to each other.

All three systems allow digital image processing and measurement capability. All three allow optional digitization of film images.

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## E. TESTING

The RadWorks™ Medical Imaging Software is tested according to the specifications that are documented in a Software Test Plan. Testing is an integral part of Applicare's software development process as described in the Software Quality Handbook.

## F. CONCLUSIONS

The RadWorks™ Medical Imaging Software is a medical device, and it has the same indications for use and target population as the legally marketed predicate devices

The RadWorks™ Medical Imaging Software has the same technological characteristics as the predicate devices.

This premarket notification describes the characteristics of the RadWorks™ Medical Imaging Software in sufficient detail to assure substantial equivalence.

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