# K130902: Emory Cardiac Toolbox 3.2

- Pathway: 510(k) (Traditional)
- Applicant: Syntermed, Inc.
- Decided: Jun 14, 2013 after 74 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: 3 generations back to K003931 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071503: System, Tomography, Computed Emission, Syntermed, Inc. (2007) Summary page 3.

## Indications for use
The Emory Cardiac Toolb'oxTM 3.2 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 gated Tc99M SPECT & PET myocardial perfusion studies (EGS™), for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface, for the assessment of cardiac mechanic dyssynchrony using phase analysis, for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either fitered backprojection (FBP) or iterative reconstruction (MLEM/OSEM), and for the quantitative analysis and display of SPECT AdreView'™ ('%’I-mIBG) data sets used for evaluation of patients with congestive heart failure. 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/K130902
Methodology: https://510kreport.com/methodology