510(k) · Cleared
ClearedEmory Cardiac Toolbox 3.2
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 Jun 14, 2013 as substantially equivalent to K071503 (Syntermed, Inc., 2007) after a 74-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Jun 14, 2013
- Review
- 74 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003931 (2001). 4 ancestors in all, the oldest K992317 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK003931 Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc. · 2001
- 2 generations backK031663 GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003
- 1 generation backK071503 System, Tomography, Computed EmissionSyntermed, Inc. · 2007
- This deviceK130902 Emory Cardiac Toolbox 3.2Syntermed, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003931 | Vivid 7 with Sonopac, Model FB0008XX | Ge Medical Systems, Inc. | 2001 | — |
| −2 | K031663 | GE Vivid 7, Model FC0003XX | General Electric Co. | 2003 | — |
| −1 | K071503 | System, Tomography, Computed Emission | Syntermed, Inc. | 2007 | — |
| 0 (this device) | K130902 | Emory Cardiac Toolbox 3.2 | Syntermed, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 18.7 · 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 |
|---|---|---|---|
| * | K071503 | System, Tomography, Computed EmissionSummary page 3…we believe is substantially equivalent to the T.I.D. and SyncTool™ analysis contained within our previous commercially released application Emory Cardiac Toolbox v3.1, KO071503. To our knowledge there have been no safety problems with the T.I.D. or SyncTool™ applications in the Emory Cardiac Toolbox v3.1… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K071503.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Toolb'oxTM 3.2 software program should be used for the quantification of myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated Tc99M SPECT & PET myocardial perfusion studies (EGS™), for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface, for the assessment of cardiac mechanic dyssynchrony using phase…
Read the full statement (156 words)
The Emory Cardiac Toolb'oxTM 3.2 software program should be used for the quantification of myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated Tc99M SPECT & PET myocardial perfusion studies (EGS™), for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface, for the assessment of cardiac mechanic dyssynchrony using phase analysis, for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either fitered backprojection (FBP) or iterative reconstruction (MLEM/OSEM), and for the quantitative analysis and display of SPECT AdreView'™ ('%’I-mIBG) data sets used for evaluation of patients with congestive heart failure.
The product is intended for use by trained nuclear technicians and nuclear medicine or nuclear cardiology physicians. The clinician remains ultimately responsible for the final interpretation and diagnosis based on standard practices and visual interpretation of all SPECT and PET data.
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/K130902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130902: Emory Cardiac Toolbox 3.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130902
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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