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510(k) Data Aggregation

    K Number
    K110366
    Device Name
    SYNGO.CT CARDIAC FUNCTION
    Manufacturer
    SIEMENS AG
    Date Cleared
    2011-04-12

    (64 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K063762,K092519,K073153,K073138
    Why did this record match?
    Device Name :

    SYNGO.CT CARDIAC FUNCTION

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

    Syngo.CT Cardiac Function is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)), evaluation tools (left and right ventricular (LV/RV) volume calculation, left ventricular myocardial wall calculation and visualization of myocardial enhancement by color coding of hypo-/hyperdense areas) and reporting tools (finding location, finding characteristics and key images), the software package is designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence of physician-identified myocardial enhancement defects and evaluation, documentation and follow-up of any such finding.

    These visualization/evaluation tools allow for quantification of functional parameters and characterization of myocardial enhancements defects over time, helping the physician to assess any changes. It is also designed to help the physician classify conspicuous regions of tissue.

    Device Description

    Syngo.CT Cardiac Function is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)), evaluation tools (left and right ventricular (LV/RV) volume calculation, left ventricular myocardial wall calculation and visualization of myocardial enhancement by color coding of hypo-/hyperdense areas) and reporting tools (finding location, finding characteristics and key images), the software package is designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence or absence of physician-identified myocardial enhancement defects and evaluation, documentation and follow-up of any such finding.

    These visualization/evaluation tools allow for quantification of functional parameters and characterization of myocardial enhancements defects over time, helping the physician to assess any changes. It is also designed to help the physician classify conspicuous regions of tissue.

    AI/ML Overview

    I am sorry, but the provided text does not contain specific acceptance criteria or an explicit study proving the device meets those criteria. The document is a 510(k) summary for the Siemens syngo.CT Cardiac Function software, primarily focused on establishing substantial equivalence to previously cleared devices.

    It mentions that "The testing results supports that all the software specifications have met the acceptance criteria" in section 10, but it does not detail:

    • What those acceptance criteria are.
    • The specifics of the study that demonstrates the device meets these criteria (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or specific performance metrics).
    • Any multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance studies with quantitative results.

    Therefore, I cannot provide the requested table and detailed information based on the given input.

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