# K223422: Emory Cardiac Toolbox 4.3

- Pathway: 510(k) (Special)
- Applicant: Syntermed
- Decided: Mar 30, 2023 after 136 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: 19 generations back to K935595 (1995). 215 ancestors in all.
No later device cites it as a predicate yet.
1 of 216 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123646: Emory Cardiac Toolbox 4.0, Syntermed, Inc. (2013) Summary page 4.
- K201034: Syngo.CT CaScoring, Siemens Medical Solutions USA, Inc. (2020) Summary page 4.
- K201632: Tomtec-Arena, Tomtec Imaging Systems GmbH (2020) Summary page 4.

## Indications for use
The Emory Cardiac Toolbox™ 4.0 – 4.3 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 (EGS™) including to quantitatively evaluate the wall motion and wall thickening of the heart using longitudinal, radial, and circumferential strain measurements, for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and analysis of the CT data to evaluate calcified plaques in the coronary arteries, 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.

Source page: https://510kreport.com/device/K223422
Methodology: https://510kreport.com/methodology