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510(k) Data Aggregation

    K Number
    K130902
    Device Name
    EMORY CARDIAC TOOLBOX 3.2
    Manufacturer
    SYNTERMED, INC.
    Date Cleared
    2013-06-14

    (74 days)

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

    SYNTERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emory Cardiac Toolbox™ 3.2 software program should be used for the quantification of myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated Tc-99m SPECT & PET myocardial perfusion studies (EGS™), for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface, for the assessment of cardiac mechanic dyssynchrony using phase analysis, for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM), and for the quantitative analysis and display of SPECT AdreView™ (133)-mlBG) data sets used for evaluation of patients with congestive heart failure. The product is intended for use by trained nuclear technicians and nuclear medicine or nuclear cardiology physicians. The clinician remains ultimately responsible for the final interpretation and diagnosis based on standard practices and visual interpretation of all SPECT and PET data.
    Device Description
    The Emory Cardiac Toolbox™ 3.2 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation (TID), and cardiac mechanic dyssynchrony. 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. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM). The Emory Cardiac Toolbox can be used with any of the following Myocardial SPECT Protocols: Same Day and Two Day Sestamibi, Dual-Isotope (Tc-99m/Tl-201), Tetrofosmin, and Thallium, Rubidium-82, N-13-ammonia, FDG protocols, and user defined normal databases. The program can also be used for the quantitative analysis and display of SPECT Adre\View™ (123)-mlBG) data sets. 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 environment. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
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    K Number
    K130451
    Device Name
    NEUROQ 3.6
    Manufacturer
    SYNTERMED, INC.
    Date Cleared
    2013-05-17

    (84 days)

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

    SYNTERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) assist with regional assessment of human brain scans, through automated quantification of mean pixel values lying within standardized regions of interest (S-ROI's), and 2) assist with comparisons of the activity in brain regions of individual scans relative to normal activity values found for brain regions in FDG-PET scans, through quantitative and statistical comparisons of S-ROI's. 3) assist with comparisons of activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data 4) NeuroQ 3.6 provides added functionality to provide analysis of amyloid uptake levels in brain regions.
    Device Description
    NeuroQ™ 3.6 has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can also be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric reqions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to provide analysis of amyloid uptake levels in the brain. This program was developed to run in the IDL operating system environment, which can be executed on any nuclear medicine computer systems which support the IDL software platform. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
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    K Number
    K123646
    Device Name
    EMORY CARDIAC TOOLBOX 4.0
    Manufacturer
    SYNTERMED, INC.
    Date Cleared
    2013-02-22

    (87 days)

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

    SYNTERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emory Cardiac Toolbox™ 4.0 software program should be used for the quantification of myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from SPECT & PET myocardial perfusion studies (EGS™), for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface, for the assessment of cardiac mechanical dyssynchrony using phase analysis, for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM), for the quantification of myocardial blood flow and coronary flow reserve, and for the decision support in interpretation (LVX) and automatic structured reporting of the study. The product is intended for use by trained nuclear technicians and nuclear medicine or nuclear cardiology physicians. The clinician remains ultimately responsible for the final interpretation and diagnosis based on standard practices and visual interpretation of all SPECT and PET data.
    Device Description
    The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation (TID), analysis of coronary blood flow and coronary flow reserve, and assessment of cardiac mechanic dyssynchrony. In addition, the program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, and expert system image interpretation. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data either filtered backprojection (FBP) or iterative reconstruction using (MLEM/OSEM). The Emory Cardiac Toolbox can be used with any of the following Myocardial SPECT Protocols: Same Day and Two Day Sestamibi, Dual-Isotope (Tc-99m/Tl-201), Tetrofosmin, and Thallium, Rubidium-82, Rubidium-82 with CTbased attenuation correction, N-13-ammonia, FDG protocols, and user defined normal databases. This program was developed to run in the .NET operating system environment which can be executed on any PC, any nuclear medicine computer system, or through a web browser. In addition, the program can be used for the decision support in interpretation and automatic structured reporting of the study. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
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    K Number
    K072307
    Device Name
    QUANTITATIVE NEUROQ 3.0
    Manufacturer
    SYNTERMED, INC.
    Date Cleared
    2008-03-14

    (210 days)

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

    SYNTERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeuroQ™-PET DP program is indicated to perform a quantitative analysis of FDG-PET brain scans using a ROI count method. NeuroQ™ 3.0 provides added functionality which allows for analyzing the difference between two FDG-PET brain studies for the same patient, calculating values within user defined regions of interest, and displaying CT and PET brain studies for the patient.
    Device Description
    NeuroQ™ 3.0 has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can also be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. This program was developed to run in the IDL operating system environment, which can be executed on any nuclear medicine computer systems which support the IDL software platform. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
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    K Number
    K071503
    Device Name
    SYSTEM, TOMOGRAPHY, COMPUTED EMISSION
    Manufacturer
    SYNTERMED, INC.
    Date Cleared
    2007-07-26

    (55 days)

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

    SYNTERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emory Cardiac Toolbox™ (CEqual®, EGS™) 3.1 software program should be used for the quantification of myocardial perfusion (CEqual®), for the display of wall motion and guantification of left-ventricular function parameters from gated Tc99m SPECT & PET myocardial perfusion studies (EGS™), for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface, for the assessment of cardiac mechanic dyssynchrony using phase anaylsys, and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM).
    Device Description
    The Emory Cardiac Toolbox™ 3.1 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation (TID), and cardiac mechanic dyssynchrony. 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. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM). The Emory Cardiac Toolbox can be used with any of the following Myocardial SPECT Protocols: Same Day and Two Day Sestamibi, Dual-Isotope (Tc-99m/Tl-201), Tetrofosmin, and Thallium, Rubidium-82, N-13-ammonia, FDG protocols, and user defined normal databases. 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 environment. The program processes the studies automatically. however, user verification of output is required and manual processing capability is provided.
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    K Number
    K070089
    Device Name
    SYNTERMED LIVE
    Manufacturer
    SYNTERMED, INC.
    Date Cleared
    2007-03-02

    (52 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Syntermed Live™ software program should be used for the transfer of medical images and data to a secure server for storage where it can subsequently be accessed, displayed, and processed on any PC connected to the Internet using either proprietary software applications, a DICOM Viewer, or a Web Browser.
    Device Description
    Syntermed Live™ is an Internet based system used to securely access, transfer, display, archive, and process medical images and data generated from a hospital or clinic. The Syntermed Live™ project is involved with the transmission and retrieval of output data files from either Syntermed proprietary applications, DICOM image files, or other medical digital data files to a Syntermed web server so that they can be archived and delivered to Syntermed customers for remote storage and review.
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    K Number
    K042258
    Device Name
    BP-SPECT V1.O
    Manufacturer
    SYNTERMED, INC.
    Date Cleared
    2004-10-04

    (45 days)

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

    SYNTERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BP-SPECT™ software program should be used for the display of wall motion and quantification of left and right ventricular function parameters from gated Tc99m blood pool SPECT studies.
    Device Description
    The BP-SPECT™ is used to display gated wall motion and for quantifying parameters of left and right ventricular from gated blood pool SPECT studies. These parameters are: ejection fraction, end-diastolic volume, end-systolic volume, stroke volume, maximum and average emptying and filling rates, ejection and filling periods and times, and regional ejection fraction. This program was developed to run in the IDL operating system environment which can be executed on any nuclear medicine computer systems which supports the IDL software development. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
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    K Number
    K041022
    Device Name
    NEUROQ - PET DP
    Manufacturer
    SYNTERMED, INC.
    Date Cleared
    2004-06-17

    (58 days)

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

    SYNTERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NeuroQ™ - PET DP Program is indicated to: - 1) assist with regional assessment of human brain scans, through automated quantification of mean pixel values lying within standardized regions of interest (S-ROI's), and - 2) assist with comparisons of the activity in brain regions of individual scans relative to normal activity values found for brain regions in FDG-PET scans, through quantitative and statistical comparisons of S-ROI's.
    Device Description
    The NeuroQ™ - PET DP Display and Analysis Program has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in and your brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. This program was developed to run in the IDL operating system environment, which can be rms program any nuclear medicine computer systems which support the IDL software platform. The program processes the studies automatically, nowever, user verification plations. The program processing capability is provided.
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    K Number
    K040141
    Device Name
    EMORY CARDIAC TOOLBOX VERSION 2.6
    Manufacturer
    SYNTERMED, INC.
    Date Cleared
    2004-01-30

    (8 days)

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

    SYNTERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emory Cardiac Toolbox™ (CEqual®, EGS™) 2.6 software program should be used for the quantification of myocardial perfusion (CEqual®), for the display of wall motion for the quantification of left-ventricular function parameters from gated Tc99m gPECT & and quantification of lell-venthcaller fanonen for the 3D alignment of coronary artery PET myocarulal perfusion studies (LES - ); and ter the left ventricular 3D epicardial surface.
    Device Description
    The Emory Cardiac Toolbox™ 2.6 is used to display gated wall motion and for quantifying The Emory Strends Tronular perfusion and function from gated SPECT & PET myocardial paramours of ices. These parameters are: perfusion, 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 the program of or are riog, prognostic information, expert system image interpretation, and patient specific 3D coronary overlay. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D of coronaly aftery models from of corenary any in the IDL operating systems which epicalular sunace. "This program was avversions on any nuclear medicine computer systems to The supports IDL and the Aladdin (General Electric) software development environment. The Supports IDL and the Riadain (Gonoral Elookie) Sownload of output is required and manual processing capability is provided.
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    K Number
    K020300
    Device Name
    NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
    Manufacturer
    SYNTERMED, INC.
    Date Cleared
    2002-04-23

    (84 days)

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

    SYNTERMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Northwestern Gated Blood Pool SPECT (NUMUGAS™) software program is indicated to use for the display of wall motion and quantification of left ventricular functional parameters from gated Tc-99m Blood Pool SPECT studies.
    Device Description
    The Northwestern Gated Blood Pool SPECT™ (NUMUGAS™) is used to display gated wall motion and for quantifying parameters of left-ventricular function from gated blood pool SPECT studies. These parameters are: ejection fraction, end-diastolic volume, endsystolic volume, stroke volume, maximum and average emptying and filling rates, ejection and filling periods and times, and regional ejection fraction. This program was developed to run in the IDL operating system environment which can be executed on any nuclear medicine computer systems which supports the IDL software development environment. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
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