# K123646: Emory Cardiac Toolbox 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Syntermed, Inc.
- Decided: Feb 22, 2013 after 87 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K913770 (1991). 63 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 67 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071503: System, Tomography, Computed Emission, Syntermed, Inc. (2007) Summary page 1.
- K992450: Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers, Emory University (1999) Summary page 1.
- K110071: Cor Analyzer, Rcadia Medical Imaging, Ltd. (2011) Summary page 1.
- K101279: CORRIDOR4DM V2010 Model: V2010, Invia (2010) Summary page 1.
- K113754: CFR Quant, University of Texas Medical School AT Houston (2012) Summary page 1.

## Most influential descendants
- K231731: Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 (2023), 1 descendant of its own
- K243881: HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 (2025), 0 descendants of its own
- K223422: Emory Cardiac Toolbox 4.3 (2023), 0 descendants of its own

## Indications for use
The Emory Cardiac ToolboxTM 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 (EGSTM), 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.

Source page: https://510kreport.com/device/K123646
Methodology: https://510kreport.com/methodology