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510(k) Data Aggregation

    K Number
    K992751
    Device Name
    SOMAVISION
    Manufacturer
    VARIAN ASSOC., INC.
    Date Cleared
    2000-02-16

    (184 days)

    Product Code
    KPQ
    Regulation Number
    892.5840
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SOMAVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Somavision is an advanced treatment planning preparation workstation for the physician and include high quality 3-D image capabilities. As part of the Varis Vision System, Somavision integrates treatment palnning in the overall therapy process, while taking advantage of the Varian Vision database.

    Device Description

    Somavision is an advanced treatment planning preparation workstation with 3D image capabilities.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for the Varian SomaVision 6.0 device. It describes the device's intended use and technological characteristics, and ultimately summarizes the FDA's decision regarding its substantial equivalence to a predicate device.

    However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

    Therefore, I cannot fulfill your request for this specific information based on the provided document. The 510(k) summary focuses on regulatory approval based on substantial equivalence, not on detailed performance study results that would typically include acceptance criteria and study methodologies.

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