# K040141: Emory Cardiac Toolbox Version 2.6

- Pathway: 510(k) (Traditional)
- Applicant: Syntermed, Inc.
- Decided: Jan 30, 2004 after 8 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: 4 generations back to K954874 (1996). 4 ancestors in all.
396 later devices descend from it; 3 cite it directly.
1 of 401 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014033: Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers, Syntermed, Inc. (2002) Summary page 1.

## Most influential descendants
- K052379: Mim 3.5 (Circa) (2005), 353 descendants of its own
- K060816: Mim 4.0 (Neuro (2006), 350 descendants of its own
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K062163: Mimviewer (2006), 166 descendants of its own

## Indications for use
The Emory Cardiac Toolbox (CEqual®, EGS) 2.6-software program should be used for the quantification of myocardial perfusion (CEqual®), for the display of wall motion and quantification of left-ventricular function parameters from gated Tc 99m SPECT & PET myocardial perfusion studies (EGS), and for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface.

Source page: https://510kreport.com/device/K040141
Methodology: https://510kreport.com/methodology