# K980914: Emory Cardiac Tool Box

- Pathway: 510(k) (Traditional)
- Applicant: Emory University
- Decided: Jun 4, 1998 after 85 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: 1 generation back to K954874 (1996). 1 ancestor in all.
405 later devices descend from it; 1 cites it directly.
1 of 407 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954874: Spectef Protocol, GE Medical Systems (1996) Summary page 1.

## Most influential descendants
- K992450: Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers (1999), 404 descendants of its own
- K014033: Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers (2002), 397 descendants of its own
- K040141: Emory Cardiac Toolbox Version 2.6 (2004), 396 descendants of its own
- K052379: Mim 3.5 (Circa) (2005), 353 descendants of its own
- K060816: Mim 4.0 (Neuro (2006), 350 descendants of its own

## Indications for use
The Emory Cardiac Tool Box™ (CEqual®,EGSTM) software program should be used for the quantification of perfusion (CEqual®) and for the display of wall motion and quantification of left-ventricular function parameters from gated TC99M SPECT myocardial perfusion studies (EGS™).

Source page: https://510kreport.com/device/K980914
Methodology: https://510kreport.com/methodology