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510(k) Data Aggregation

    K Number
    K982060
    Device Name
    VOLUMAX CT IMAGING SYSTEM
    Manufacturer
    ELSCINT, INC.
    Date Cleared
    1998-09-02

    (83 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K964583,K941546,K964747,K932271,K945512,K961464,K954678
    Why did this record match?
    Reference Devices :

    K964583, K941546, K964747, K932271

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

    The Volumax is used for whole body computed tomography.

    Whole body computerized tomography.

    Device Description

    The Volumax is a continuous rotation CT scanner consisting of a gantry, patient table, operator station and accessories. Its main characteristics are:

    • Continuous rotation and Helix (spiral) scanning. .
    • Simultaneous multi-slice scanning. .
    • Minimum scan time of 0.3 second. .
    • Minimum reconstruction time of 0.5 second. .
    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for the Volumax CT scanner, focusing on its intended use, features, predicate devices, and a statement of substantial equivalency. It highlights adherence to safety standards (GMP, IEC 601-1, 21 CFR Subchapter J) but does not detail performance metrics or studies to demonstrate them against specific acceptance criteria.

    Therefore, I cannot provide the requested table and study details.

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