510(k) · Cleared
ClearedFullcard Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · KPS System, Tomography, Computed, Emission
Cleared on Jun 23, 2006 as substantially equivalent to K040141 (Syntermed, Inc., 2004) and 3 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Jun 23, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K954874 (1996). 20 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 4 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 3 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 2 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 1 generation backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- This deviceK061587 Fullcard AnalysisGE Healthcare · 2006
- Descendant · cites it directly · 0 of its ownK192277 CardIQ FlowGE Medical Systems SCS · 2020
Most influential descendants
Showing 1 of 1 · See all- K192277CardIQ FlowGE Medical Systems SCS · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −4 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −3 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −2 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −1 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| 0 (this device) | K061587 | Fullcard Analysis | GE Healthcare | 2006 | — |
| +1 | K192277 | CardIQ Flow | GE Medical Systems SCS | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040141 | Emory Cardiac Toolbox Version 2.6Summary page 1…WI 53210 Marketed Devices FullCard Analysis is substantially equivalent to the devices listed below: * Model: ECToolbox with HeartFusion; K040141 * Manufacturer: General Electric Medical Systems, Buc, France * Model: Xeleris 2 Processing… | 2004 |
| * | K051673 | Xeleris 2 Processing and Review WorkstationSummary page 1…artFusion; K040141 * Manufacturer: General Electric Medical Systems, Buc, France * Model: Xeleris 2 Processing and Review WorkstationK051673 * Manufacturer: General Electric Medical Systems, Haifa, Israel * Model: Advantage Workstati… | 2005 |
| * | K052995 | Advantage Workstation 4.3.Summary page 1…ng and Review WorkstationK051673 * Manufacturer: General Electric Medical Systems, Haifa, Israel * Model: Advantage Workstation 4.3; K052995 * Manufacturer: General Electric Medical Systems, Buc, France * Model: Positron mPower; K022… | 2005 |
| * | K022001 | Mpower, Model 712 SeriesSummary page 1…Advantage Workstation 4.3; K052995 * Manufacturer: General Electric Medical Systems, Buc, France * Model: Positron mPower; K022001 * Manufacturer: Positron Corporation, Houston, TX, USA Device Description: FullCard Analysis (FCA) is a post pr… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192277 | CardIQ Flow | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 7 of the 20 ancestors have a recall of any class.
- Of its descendants, K192277 (GE Medical Systems SCS, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K040141.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
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…
Read the full statement (224 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061587 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061587: Fullcard Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061587
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026