LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K992450
    Device Name
    EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
    Manufacturer
    EMORY UNIVERSITY
    Date Cleared
    1999-10-07

    (77 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMORY UNIVERSITY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emory Cardiac Toolbox™ (CEqual®, EGS™) 2.0 software program should be used for the quantification of myocardial perfusion (CEqual®) and for the display of wall motion and quantification of left-ventricular function parameters from gated Tc99m SPECT myocardial perfusion studies (EGS™).
    Device Description
    The Emory Cardiac Tool Box™ 2.0 is used to display gated wall motion and for quantifying parameters of left-ventricular from gated SPECT myocardial perfusion studies. These parameters are: ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass and transient ischemic dilatation (TID). In addition, the program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, expert system image interpretation, and patient specific 3D coronary overlay. This program was developed to run in the IDL operating system environment which can be executed on any nuclear medicine computer systems which supports IDL and the Aladdin (General Electric) software development . The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
    Ask a Question
    K Number
    K980914
    Device Name
    EMORY CARDIAC TOOL BOX
    Manufacturer
    EMORY UNIVERSITY
    Date Cleared
    1998-06-04

    (85 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMORY UNIVERSITY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emory Cardiac Tool Box™ (CEqual®,EGS™) software program should be used for the quantification of perfusion (CEqual®) and for the display of wall motion and quantification of left-ventricular function parameters from gated TC99m SPECT myocardial perfusion studies (EGSTM).
    Device Description
    The Emory Cardiac Tool Box™ (CEqual®, EGS™) is used to display gated wall motion and for quantifying parameters of left-ventricular from gated SPECT myocardial perfusion studies. These parameters are: ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass and transient ischemic dilatation (TID). This program was developed to run in the IDL operating system environment and can be executed on any nuclear medicine computer systems which supports IDL. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
    Ask a Question

    Page 1 of 1