(39 days)
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No
The document describes standard medical image viewing and processing software without mentioning AI or ML capabilities. The description of image processing is generic and does not imply advanced AI/ML techniques. There is no mention of training or test sets related to AI/ML model development.
No.
The document describes a medical imaging software system used for viewing, retrieving, storing, importing, processing, and transmitting medical images. It does not mention any therapeutic function or the ability to treat or cure diseases.
No
The device is described as medical imaging software that enables radiologists to view, retrieve, store, import, process, and transmit medical images. While it processes images, it does not explicitly state that it provides a diagnosis or aids in making a diagnosis.
Yes
The device is described as a "stand-alone software product" that runs on a standard operating system and hardware, with the only optional hardware being a special graphics card, which is a common component for image processing software and doesn't make the device itself a hardware device.
Based on the provided information, the RadWorks™ Medical Imaging Software is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens taken from the human body. The description of RadWorks™ focuses on processing and displaying medical images (CT, MRI, CR, US) which are generated from imaging the body directly, not from analyzing biological samples.
- The intended use and device description clearly indicate its function is for viewing, processing, and managing medical images. This aligns with the definition of a medical image management and processing system, not an IVD.
- There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD testing.
Therefore, RadWorks™ is a medical imaging software, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
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 NTT™ 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.
Mentions image processing
All three systems allow digital image processing and measurement capability.
Mentions AI, DNN, or ML
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Input Imaging Modality
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.
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
radiologists and other medical specialists
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The RadWorks™ Medical Imaging Software is tested according to the specifications that are documented in a Software Test Plan and Quality Handbook.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.2020 Medical image communications device.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
5 July, 1996
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: (+31) 172 449 111 Fax: (+31) 172 449 129 E-mail: R.Kroon@applicare.nl
Contact: Ruud Kroon Prepared: July 5, 1996
LEGALLY MARKETED PREDICATE DEVICES A.
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).
DEVICE DESCRIPTION B.
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 NTT™ 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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Applicare Medical Imaging B.V.
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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 grev 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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TECHNOLOGICAL CHARACTERISTICS D.
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 All (Mode Tyclering 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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3
TESTING E.
The RadWorks™ Medical Imaging Software is tested according to the specifications that are documented
ed the success of the Taction, in an integral part, of Applicare's softw The RadWorks™ Medical Imaging Software is tested according to the Specifications national of the Research and the formers as
in a Software Safeware In a Software Test Plant Quality Handbook.
CONCLUSIONS ப்
The RadWorks™ Medical Imaging Software is a medical device, and it has the same indications for a
reas and the same the largily devices The RadWorks™ Medical Imaging Soltware is a most
use and target population as the legally marketed predicate devices
as and of predicate devices.
prediction of the characteristics of the RadWorks™ Medical Imaging Software
This procession in a whotential orgivalence This prematicel notification assure substantial equivalence.
in sufficient detail to assure substantial equivalence.
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