510(k) · Cleared
ClearedSystem, Tomography, Computed Emission
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 Jul 26, 2007 as substantially equivalent to K992317 (Adac Laboratories, 1999) and 1 other predicate after a 55-day review. Its family tree reaches back 2 generations to 2001. 5 later devices descend from it.
- Decided
- Jul 26, 2007
- Review
- 55 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003931 (2001). 3 ancestors in all, the oldest K992317 (1999). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK003931 Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc. · 2001
- 1 generation backK031663 GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003
- This deviceK071503 System, Tomography, Computed EmissionSyntermed, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK123646 Emory Cardiac Toolbox 4.0Syntermed, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK231731 Optional Screen Displays for HeartSee Cardiac P.E.T. Processing…Mcgovern Medical School · 2023
- Descendant · 3 generations on · 0 of its ownK243881 HeartSee™ Cardiac P.E.T. Processing Software For Myocardial…Bracco Diagnostics, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK223422 Emory Cardiac Toolbox 4.3Syntermed · 2023
- Descendant · cites it directly · 0 of its ownK130902 Emory Cardiac Toolbox 3.2Syntermed, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K123646Emory Cardiac Toolbox 4.0Syntermed, Inc. · 2013 · cites it directly3descendants
- K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School · 2023 · 2 generations on1descendant
- K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc. · 2025 · 3 generations on0descendants
- K223422Emory Cardiac Toolbox 4.3Syntermed · 2023 · 2 generations on0descendants
- K130902Emory Cardiac Toolbox 3.2Syntermed, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003931 | Vivid 7 with Sonopac, Model FB0008XX | Ge Medical Systems, Inc. | 2001 | — |
| −1 | K031663 | GE Vivid 7, Model FC0003XX | General Electric Co. | 2003 | — |
| 0 (this device) | K071503 | System, Tomography, Computed Emission | Syntermed, Inc. | 2007 | — |
| +1 | K123646 | Emory Cardiac Toolbox 4.0 | Syntermed, Inc. | 2013 | — |
| +2 | K231731 | Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software -… | Mcgovern Medical School | 2023 | — |
| +3 | K243881 | HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and… | Bracco Diagnostics, Inc. | 2025 | — |
| +2 | K223422 | Emory Cardiac Toolbox 4.3 | Syntermed | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K992317 | Autospect Plus with Instill Motion CorrectionSummary page 1…puter systems and Windows PC's. Classification Name - System, Tomography, Computed, Emission 3.Medical Device Equivalence: AutoSPECT Plus developed by ADAC Laboratories K992317 for Emory Reconstruction Toolbox (ERTb T m) and GE Vivid 7 Diagnostic Ultrasound System with TSI developed by GE Medical Systems… | 1999 |
| * | K031663 | GE Vivid 7, Model FC0003XXSummary page 1…s developed by ADAC Laboratories K992317 for Emory Reconstruction Toolbox (ERTb T m) and GE Vivid 7 Diagnostic Ultrasound System with TSI developed by GE Medical Systems K03 1663 for Phase Analysis. 4.Device Description: The Emory Cardiac ToolboxTM 3.1 is used to display gated wall motion and for quantifyi… | 2003 |
| † | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | 1999 |
| † | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | 2002 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K123646 (Syntermed, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K992317.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Toolbox TM (CEqual®, EGS TM ) 3.1 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 Tc9 9 m SPECT & PET myocardial perfusion studies (EGSTM), for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface, for the assessment of cardiac mechariic dyssynchrony using phase anaylsys, and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071503: System, Tomography, Computed Emission.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071503
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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