# K061587: Fullcard Analysis

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Jun 23, 2006 after 15 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: 5 generations back to K954874 (1996). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040141: Emory Cardiac Toolbox Version 2.6, Syntermed, Inc. (2004) Summary page 1.
- K051673: Xeleris 2 Processing and Review Workstation, GE Medical Systems (2005) Summary page 1.
- K052995: Advantage Workstation 4.3., GE Healthcare (2005) Summary page 1.
- K022001: Mpower, Model 712 Series, Positron Corp. (2002) Summary page 1.

## Most influential descendants
- K192277: CardIQ Flow (2020), 0 descendants of its own

## Indications for use
FCA is an aiding tool for the clinicians to perform analysis of sets of stationary, dynamic, or gated PET transaxial images via a number of display, measurement and batch filming/archive features. The measurements include perfusion, end-diastolic & end-systolic volumes, stroke volume, ejection fraction, myocardial mass, and transient ischemic dilatation. Also included is to enable clinicians to visualize reformatted PET perfusion and viability data, make a comparison between the two. The perfusion or viability data could have been acquired under stress or rest conditions and they can be processed individually or simultaneously. FCA allows users to customize their screens. Also, the users can export a selected set of short axis images in DICOM compliant format. These images can then be processed by an external software package to perform regional quantitative analysis, absolute and relative ratio maps of each region of the heart and topographic maps. Finally, it aids clinicians to capture the summary of quantitative and qualitative results from the study in a single summary page. The physiological and functional data could come from the same scanner as in the case of PET/CT scanner; or they could come from separate scanners. In summary, FCA is intended to aid clinicians in the assessment of physiological data and in refining their clinical decisions based on the quantitative and qualitative assessment of stationary, dynamic, and gated PET images.

Source page: https://510kreport.com/device/K061587
Methodology: https://510kreport.com/methodology