Cardiac Toolbox

GUDID B133ECTB422512090

The Cardiac Toolbox™ 4.2 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies 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 IDB133ECTB422512090
NIH Device Record Keya6de3613-c4a3-4ac4-94a5-c714002e82f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardiac Toolbox
Version Model Number4.2.9474.37928
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
HIBCCB133ECTB422512090 [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 Date2026-03-06
Device Publish Date2026-02-26

Devices Manufactured by SYNTERMED INCORPORATED

B133ECTB422512090 - Cardiac Toolbox2026-03-06The Cardiac Toolbox™ 4.2 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies 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.
B133ECTB422512090 - Cardiac Toolbox2026-03-06 The Cardiac Toolbox™ 4.2 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and
B133NEUROQ412507140 - NeuroQ2025-08-14 The NeuroQ™ 3.8- 4.1 program is used to regionally quantify activity in brain PET and SPECT scans using a ROI count method. I
B133ECTB4225063000 - Emory Cardiac Toolbox2025-08-11 The Emory Cardiac Toolbox™ 4.2 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusi
B133NEUROQ402505160 - NeuroQ2025-06-26 The NeuroQ™ 3.8- 4.0 program is used to regionally quantify activity in brain PET and SPECT scans using a ROI count method. I
B133ECTB422503240 - Emory Cardiac Toolbox2025-04-03 The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusi
B133NEUROQ402503120 - NeuroQ2025-03-31 The NeuroQ™ 3.8- 4.0 program is used to regionally quantify activity in brain PET and SPECT scans using a ROI count method. I
B133NEUROQ40241250 - NeuroQ2025-02-04 The NeuroQ™ 3.8- 4.0 program is used to regionally quantify activity in brain PET and SPECT scans using a ROI count method. I
B133ECTB422403260 - Emory Cardiac Toolbox2024-04-23 The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusi
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