# K032500: Modificarion to Wackers-Liu CQ Software

- Pathway: 510(k) (Special)
- Applicant: Eclipse Systems, Inc.
- Decided: Aug 25, 2003 after 12 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 K002229 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002229: Wackers-Liu CQ Software, Eclipse Systems, Inc. (2000) Summary page 1.

## Indications for use
The revised Wackers-Liu CQ" Software is a stand-alone software package for quantification of emission computed tomography (ECT) myocardial perfusion images. The data generated by the Wackers-Liu CQ" Software is intended to be used by the physician in addition to other complementary data in the evaluation of cardiac fknction and blood supply. It is not meant to replace or eliminate the physician's standard visual interpretation of the patient study or the integration of additional clinical andor diagnostic information (patient history, stress andor rest EKG, echocardiogram, etc.) prior to making any final clinical diagnostic or treatment decision. The Wackers-Liu CQ" Software also provides for transmission of ECT images over the internet.

Source page: https://510kreport.com/device/K032500
Methodology: https://510kreport.com/methodology