510(k) · Cleared
ClearedEmory Cardiac Toolbox Version 2.6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntermed, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Jan 30, 2004 as substantially equivalent to K014033 (Syntermed, Inc., 2002) after an 8-day review. Its family tree reaches back 4 generations to 1996. 1 of the 401 devices in its family, counting itself, has a Class I recall. 396 later devices descend from it.
- Decided
- Jan 30, 2004
- Review
- 8 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954874 (1996). 396 later devices descend from it, 3 citing it directly. 1 of the 401 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 3 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 2 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 1 generation backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- This deviceK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- Descendant · cites it directly · 353 of its ownK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- Descendant · 2 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 3 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 4 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 166 of its ownK062163 MimviewerMimvista Corp. · 2006
Showing 5 of 396 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 396 · See all- K052379Mim 3.5 (Circa)Mimvista Corp. · 2005 · cites it directly353descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 2 generations on350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 3 generations on287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 4 generations on200descendants
- K062163MimviewerMimvista Corp. · 2006 · 3 generations on166descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −3 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −2 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −1 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| 0 (this device) | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| +1 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| +2 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +3 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 10 | 0 |
| 2013 | 9 | 0 |
| 2014 | 11 | 0 |
| 2015 | 13 | 0 |
| 2016 | 18 | 0 |
| 2017 | 18 | 0 |
| 2018 | 25 | 0 |
| 2019 | 24 | 0 |
| 2020 | 31 | 0 |
| 2021 | 25 | 0 |
| 2022 | 35 | 0 |
| 2023 | 31 | 0 |
| 2024 | 31 | 0 |
| 2025 | 48 | 1 |
| 2026 | 41 | 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.
1 device in this family has a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSummary page 1…. Classification Name - System, Tomography, Computed, Emission 3. Medical Device Equivalence: Emory Cardiac Toolbox TM (CEqual®, EGS T M ) Version 2.1, Ref. 510(k) #: K014033. 4. Device Description: The Emory Cardiac Toolbox TM 2.6 is used to display gated wall motion and for quantifying parameters of… | 2002 |
| † | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | 1999 |
What descends from it? (396)
See all 3963 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K052379 (Mimvista Corp., 2005) has gone furthest, with 353 descendants of its own.
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?
The Emory Cardiac Toolbox (CEqual®, EGS) 2.6-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 Tc 99m SPECT & PET myocardial perfusion studies (EGS), and for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040141: Emory Cardiac Toolbox Version 2.6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040141
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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