Emory Cardiac Toolbox

GUDID B133ECTB422503240

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.

SYNTERMED INCORPORATED

Multidisciplinary medical image management software
Primary Device IDB133ECTB422503240
NIH Device Record Keyf8f4fd4e-64c7-4a95-9fda-0620b9398544
Commercial Distribution Discontinuation2025-03-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEmory Cardiac Toolbox
Version Model Number4.2.9214.18548
Company DUNS113727205
Company NameSYNTERMED INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB133ECTB422503240 [Primary]

FDA Product Code

KPSSystem, Tomography, Computed, Emission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-03
Device Publish Date2025-03-26

On-Brand Devices [Emory Cardiac Toolbox]

B133ECTB40The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame
B133ECTB422102190The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame
B133ECTB422112080The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame
B133ECTB42221031The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame
B133ECTB42231102The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame
B133ECTB422403260The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame
B133ECTB422503240The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame
B133ECTB4225063000The Emory Cardiac Toolbox™ 4.2 is used to display gated wall motion and for quantifying parame
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