510(k) · Cleared
ClearedEmory Cardiac Tool Box
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emory University · KPS System, Tomography, Computed, Emission
Cleared on Jun 4, 1998 as substantially equivalent to K954874 (GE Medical Systems, 1996) after an 85-day review. Its family tree reaches back 1 generation to 1996. 1 of the 407 devices in its family, counting itself, has a Class I recall. 405 later devices descend from it.
- Decided
- Jun 4, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954874 (1996). 405 later devices descend from it, 1 citing it directly. 1 of the 407 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK954874 Spectef ProtocolGE Medical Systems · 1996
- This deviceK980914 Emory Cardiac Tool BoxEmory University · 1998
- Descendant · cites it directly · 404 of its ownK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- Descendant · 2 generations on · 397 of its ownK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- Descendant · 3 generations on · 396 of its ownK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- Descendant · 4 generations on · 353 of its ownK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- Descendant · 5 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
Showing 5 of 405 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…12 generations on · 2025
Most influential descendants
Showing 5 of 405 · See all- K992450Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999 · cites it directly404descendants
- K014033Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002 · 2 generations on397descendants
- K040141Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004 · 3 generations on396descendants
- K052379Mim 3.5 (Circa)Mimvista Corp. · 2005 · 4 generations on353descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 5 generations on350descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| 0 (this device) | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| +1 | 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 | — |
| +3 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| +4 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| +5 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 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 | 10 | 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 | 33 | 0 |
| 2024 | 31 | 0 |
| 2025 | 49 | 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 18.7 · 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 |
|---|---|---|---|
| * | K954874 | Spectef ProtocolSummary page 1…rdial perfusion studies executing on nuclear medicine computer systems. 3. Medical Device Equivalence: SPECTEF Protocol developed by GE Medical Systems, Ref. 510(k) #: K954874. 4. Devige-Description: The Emory Cardiac Tool Box™ (CEqual@; EGS™) is used to display gated wall motion and for quantifying pa… | 1996 |
What descends from it? (405)
See all 4051 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | 1999 | 404 |
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 · 12 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K992450 (Emory University, 1999) has gone furthest, with 404 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 Tool Box™ (CEqual®,EGSTM) software program should be used for the quantification of perfusion (CEqual®) and for the display of wall motion and quantification of left-ventricular function parameters from gated TC99M SPECT myocardial perfusion studies (EGS™).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980914 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980914: Emory Cardiac Tool Box.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980914
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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