# K071503: System, Tomography, Computed Emission

- Pathway: 510(k) (Traditional)
- Applicant: Syntermed, Inc.
- Decided: Jul 26, 2007 after 55 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: 2 generations back to K003931 (2001). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992317: Autospect Plus with Instill Motion Correction, Adac Laboratories (1999) Summary page 1.
- K031663: GE Vivid 7, Model FC0003XX, General Electric Co. (2003) Summary page 1.

## Most influential descendants
- K123646: Emory Cardiac Toolbox 4.0 (2013), 3 descendants of its own
- 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
- K130902: Emory Cardiac Toolbox 3.2 (2013), 0 descendants of its own

## Indications for use
The Emory Cardiac Toolbox TM (CEqual®, EGS TM ) 3.1 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 Tc9 9 m 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 mechariic dyssynchrony using phase anaylsys, and 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).

Source page: https://510kreport.com/device/K071503
Methodology: https://510kreport.com/methodology