Emory Cardiac Toolbox

Primary DI
B133ECTB422009110
Brand
Emory Cardiac Toolbox
Company
SYNTERMED INCORPORATED
Model
4.2.7559.13747
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 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, Rubidium-82 with CT-based 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.
Published
2020-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KPSSystem, Tomography, Computed, Emission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPSSystem, Tomography, Computed, EmissionRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123646000EMORY CARDIAC TOOLBOX 4.0Syntermed, Inc.2013-02-22KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B133ECTB422009110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multidisciplinary medical image management softwareA software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching); it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition.

Regulatory Flags#

DUNS number
113727205
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B133NEUROQ412601160NeuroQ4.1.0060-r202601162026-03-04
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B133NEUROQ412507140NeuroQ4.1.0036-r202507142025-08-06
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B133NEUROQ402505160NeuroQ4.0.9995-r202505162025-06-18
B133ECTB422503240Emory Cardiac Toolbox 4.2.9214.185482025-03-26
B133ECTB422403260Emory Cardiac Toolbox4.2.8851.244802024-04-15
B133NEUROQ402503120NeuroQ4.0.9993.r202503122025-03-21
B133NEUROQ40241250NeuroQ4.0.991.r112025-01-27
B133ECTB42231102Emory Cardiac Toolbox4.28706.220362023-11-14
B133ECTB42221031Emory Cardiac Toolbox4.2.8339.225562023-04-24
B133ECTB400Emory Cardiac Toolbox4.2.7003.285862020-11-12
B133NEUROQ300NeuroQ3.82020-11-12
B133ECTB422112080Emory Cardiac Toolbox4.27720.294732021-12-28
B133NEUROQ382112070NeuroQ3.80.20210429.1432552021-12-28
B133NEUROQ382104290NeuroQ3.80.20210429.1432552021-05-27
B133ECTB422102190Emory Cardiac Toolbox4.27720.294732021-02-28
B133NEUROQ1NeuroQ3.75.201710192018-06-29
B133ECTB40Emory Cardiac Toolbox4.0.5121.180012016-04-07
B133NEUROQ0NeuroQ3.6.201311272016-04-07

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