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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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The Philips OmniDiagnost is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.

The OmniDiagnost is a multifunctional, universal, overtable X-Ray system offering fluoroscopic, radiographic, angiographic and interventional techniques in a wide variety of applications. The OmniDiagnost employs a scanning concept, whereby the column with X-Ray tube and Image Intensifier moves while the table remains fixed.

The basic system is composed of the OmniDiagnost stand, X-Ray generator, X-Ray tube and collimator, II-TV subsystem and monitors, Control Desks, Digital Acquisition System (DSI (K920793)), and Easy Vision (initially introduced under K920950).

This document describes a 510(k) submission for the Philips OmniDiagnost, a remote-controlled radiographic/fluoroscopic system. As such, the information you've requested regarding acceptance criteria and a study proving the device meets those criteria is not typically present in this type of regulatory submission.

510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device already legally marketed. This means the new device has the same intended use, technological characteristics, and safety and effectiveness as a predicate device, or if there are differences, those differences do not raise new questions of safety and effectiveness.

Therefore, the sections you've requested like "acceptance criteria" and details of a "study that proves the device meets the acceptance criteria" in terms of performance metrics (sensitivity, specificity, etc., with sample sizes, ground truth, expert qualifications) are not applicable to this 510(k) document.

Here's why and what information is provided:

• Acceptance Criteria & Reported Device Performance: This type of information is generally for devices with quantifiable performance metrics, often software algorithms or diagnostic tests. For an X-ray system, the "acceptance criteria" revolve around demonstrating that the image quality, radiation dose, and functional capabilities are at least as good as, and do not introduce new risks compared to, the predicate device. The document does not specify quantified acceptance criteria or performance metrics in this format.

• Study Details (Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone): These are all relevant to clinical performance studies, especially for AI/algorithm-driven devices for diagnosis or screening. The Philips OmniDiagnost is a hardware system; its performance is assessed against established X-ray system standards and by demonstrating equivalence to a known predicate device. There is no mention of a human-in-the-loop study, standalone algorithm performance, or a test set with expert-established ground truth because these concepts don't directly apply to the regulatory approval process presented here for a radiographic/fluoroscopic system.

• Training Set Sample Size & Ground Truth: Similarly, these are for machine learning models. The OmniDiagnost doesn't describe an AI component that would require a "training set."

What the document does provide in relation to regulatory approval:

1. Device Name: Philips OmniDiagnost
2. Product Code: 90 JAA
3. Classification Name: Fluoroscopic X-Ray System, 21 CFR 892.1680
4. Intended Use: Diagnostic imaging for radiographic, fluoroscopic, angiographic, and interventional applications.
5. Predicate Device: Philips Diagnost 96 (FDA ref. K912470)
6. Substantial Equivalence Claim: The OmniDiagnost is described as a "modification of, and substantially equivalent to the Philips Diagnost 96 system."
7. Safety Information: Complies with applicable portions of 21 CFR parts 1020.30/.31/.32 and voluntary safety standards, such as UL 2601.

In summary, because this is a 510(k) submission for an X-ray imaging system rather than a diagnostic algorithm or software, the detailed performance study information you've requested is not found in the provided text. The "study" for this type of device involves demonstrating that its technical specifications, image quality, and safety features are equivalent to those of a pre-existing, legally marketed device (the predicate).

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The TRS 2000 system is a teleradiology system/transmission and advance reviewing station X-ray images. TRS 2000 is used for advanced reviewing and transmission over private or public telecommunications networks of radiological images.

The TRS 2000 system is a teleradiology system/transmission and advance reviewing station X-ray images.

This document is a 510(k) summary for the SECTRA Teleradiology System TRS 2000, dated May 15, 1996. It asserts the system's substantial equivalence to the Philips PMS Easy Vision (K920950) and discusses its safety and effectiveness.

However, the provided text does not contain the specific information needed to answer the request about acceptance criteria and a study proving those criteria are met.

Here's why and what information is missing:

• No specific acceptance criteria: The document states the system is "safe and effective" and complies with federal performance standards and voluntary standards, but it doesn't list quantifiable performance metrics as acceptance criteria (e.g., sensitivity, specificity, accuracy, image resolution targets, transmission speed guarantees).
• No detailed study description: While it mentions "substantial independent experience from clinical operation" and "close co-operation with radiologists from the specifications to test phases," it does not describe a formal study with the elements requested (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).

Therefore, based only on the provided text, I cannot complete the table or answer the specific questions about the study. The document is a regulatory summary, not a detailed scientific study report.

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