Emory Cardiac Toolbox

GUDID B133ECTB42221031

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

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• Primary Device ID: B133ECTB42221031
• NIH Device Record Key: 5dbaf278-5edd-4cbf-8925-7ea66c525ea7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Emory Cardiac Toolbox
• Version Model Number: 4.2.8339.22556
• Company DUNS: 113727205
• Company Name: SYNTERMED INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B133ECTB42221031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123646

FDA Product Code

• KPS: System, Tomography, Computed, Emission

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-02
• Device Publish Date: 2023-04-24

On-Brand Devices [Emory Cardiac Toolbox]

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• B133ECTB422102190: The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame
• B133ECTB422112080: The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame
• B133ECTB42221031: The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame
• B133ECTB42231102: The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame
• B133ECTB422403260: The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame