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510(k) Data Aggregation

    K Number
    K012106
    Device Name
    ACCUIMAGE SMARTGATE UPGRADE
    Manufacturer
    ACCUIMAGE DIAGNOSTICS CORP.
    Date Cleared
    2001-09-25

    (81 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K980169,K003230
    Why did this record match?
    Device Name :

    ACCUIMAGE SMARTGATE UPGRADE

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

    Heart calcium scoring for gated CT images to minimize effects of heart movements.

    Device Description

    The Acculmage Smartgate Upgrade for AccuScore 1.0 is an additional The Accumlage Onlangate Openalic Imaging Workstation with AccuScore, AccuAnalyze, AccuShade, AccuVRT and AccuMIP plugwin 7 locaboore, Accuring is not currently marketed, and the AccuMIP ins. The Accuremade play ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . play-in-15-ourrently-our-en-in-stating Tool enhancement for AccuScore Accumage Onlangulo Opgrado Stimas scoring for gated images, thus minimizing adverse effects of heart movement.

    AI/ML Overview

    The provided text is a 510(k) Summary for the AccuImage SmartGate Upgrade. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's description, intended use, and general safety considerations.

    The document does NOT contain information regarding:

    • Specific acceptance criteria for device performance.
    • A detailed study proving the device meets acceptance criteria.
    • Reported device performance metrics.
    • Sample sizes for test sets or their data provenance.
    • Number of experts or their qualifications for ground truth establishment.
    • Adjudication methods.
    • Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
    • Standalone performance study results.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    Instead, the document states:

    • Substantial Equivalence: The AccuImage Smartgate Upgrade Option is substantially equivalent to GE Medical Systems HiSpeed Lxi with SmartScore and the Vital Images Vscore with Gating options. This is the primary method of validation presented.
    • Performance Testing: "All software testing specified in the Software Product Development Plan will be successfully completed prior to market release." However, no details of this testing or its results are provided.
    • Software Development: The software was "designed, developed, verified and validated according to which procedure for developing and approving product organizations, software colling and testing, validation testing and field maintenance." Again,
      no specifics on the results of these processes are given.
    • Hazard Analysis: Performed throughout development, concluding that the "Level of Concern" is "Minor" and that no failures are expected to materially contribute to patient death or injury.

    In summary, the provided text does not contain the specific information requested in your prompt regarding acceptance criteria, study details, and performance metrics. It's a regulatory submission focused on substantial equivalence rather than a detailed performance study report.

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