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510(k) Data Aggregation
(10 days)
ViewForum 2003 is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shell" standard computer components. ViewForum 2003 software receives image data from medical scanning devices such as CT and MRI, or from image archives. It performs viewing, image manipulation, communication, printing and quantification of images.
The device is a software package able to run on "off the shelf" hardware components. The basic functions of ViewForum 2003 are viewing, printing, storing, communications, transferring and quantifying images. The incorporation of the DICOM standard for medical network protocols transfers, an interface between the various system components and information exchange is facilitated, this provides compatibility with diagnostic imaging systems, printers, archival and review stations from many manufacturers. The product will also be made available as a Plug-in version for use on other modality Workstations such as CT, PACS etc. which use suitable Hardware components.
This 510(k) summary (K032096) for the Philips ViewForum 2003 Image Processing System does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices (Philips EasyVision Workstation and Philips EasyVision Workstation Release 6) by describing the device's general functions, intended use, and safety information. It states that "No new hazards are introduced by the development of ViewForum 2003" and that "Hazards known during the lifecycle of the predecessor Easy Vision Workstation are again considered and measurements are taken." However, it does not provide details about specific performance metrics, clinical studies, or the results of such studies.
Therefore, I cannot provide the requested information in the table format or answer the questions related to sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance for this specific device based on the provided text. This type of information is typically required for more complex devices, especially those involving AI/ML components for diagnostic purposes, which was not the case for this image processing workstation from 2003.
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