510(k) · Cleared
ClearedEmory Cardiac Toolbox 4.0
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 Feb 22, 2013 as substantially equivalent to K071503 (Syntermed, Inc., 2007) and 4 other predicates after an 87-day review. Its family tree reaches back 12 generations to 1991. 1 of the 67 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Feb 22, 2013
- Review
- 87 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K913770 (1991). 63 ancestors in all, the oldest K892358 (1989). 3 later devices descend from it, 2 citing it directly. 1 of the 67 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK063548 Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd. · 2007
- 2 generations backK072242 Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd. · 2007
- 1 generation backK110071 Cor AnalyzerRcadia Medical Imaging, Ltd. · 2011
- This deviceK123646 Emory Cardiac Toolbox 4.0Syntermed, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK231731 Optional Screen Displays for HeartSee Cardiac P.E.T. Processing…Mcgovern Medical School · 2023
- Descendant · 2 generations on · 0 of its ownK243881 HeartSee™ Cardiac P.E.T. Processing Software For Myocardial…Bracco Diagnostics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK223422 Emory Cardiac Toolbox 4.3Syntermed · 2023
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 10 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 9 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 8 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 7 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 6 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 5 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 4 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 3 generations backK063548 Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd. · 2007
- 2 generations backK072242 Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd. · 2007
- 1 generation backK110071 Cor AnalyzerRcadia Medical Imaging, Ltd. · 2011
- This deviceK123646 Emory Cardiac Toolbox 4.0Syntermed, Inc. · 2013
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…3 generations back · 1999
Most influential descendants
Showing 3 of 3 · See all- K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School · 2023 · cites it directly1descendant
- K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc. · 2025 · 2 generations on0descendants
- K223422Emory Cardiac Toolbox 4.3Syntermed · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −10 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −9 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −8 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −7 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −6 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −5 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −4 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −3 | K063548 | Cor Analyzer 1, Version 1.4 | Rcadia Medical Imaging, Ltd. | 2007 | — |
| −2 | K072242 | Cor Analyzer II, Model V1.7 | Rcadia Medical Imaging, Ltd. | 2007 | — |
| −1 | K110071 | Cor Analyzer | Rcadia Medical Imaging, Ltd. | 2011 | — |
| 0 (this device) | K123646 | Emory Cardiac Toolbox 4.0 | Syntermed, Inc. | 2013 | — |
| +1 | K231731 | Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software -… | Mcgovern Medical School | 2023 | — |
| +2 | K243881 | HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and… | Bracco Diagnostics, Inc. | 2025 | — |
| +1 | K223422 | Emory Cardiac Toolbox 4.3 | Syntermed | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 1 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (5)
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 1…ms and Windows PC's. Classification Name - System, Tomography, Computed, Emission 3. Medical Device Equivalence: Emory Cardiac Toolbox v3.1 K071503, Emory Cardiac Toolbox v2.0 K992450 (PERFEX), COR Analyzer developed by Rcadia K110071, CORRIDOR 4DM V2010 deve… | 2007 |
| * | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersSummary page 1…ification Name - System, Tomography, Computed, Emission 3. Medical Device Equivalence: Emory Cardiac Toolbox v3.1 K071503, Emory Cardiac Toolbox v2.0 K992450 (PERFEX), COR Analyzer developed by Rcadia K110071, CORRIDOR 4DM V2010 developed by INVIA K101279, and Coronary… | 1999 |
| * | K110071 | Cor AnalyzerSummary page 1…3. Medical Device Equivalence: Emory Cardiac Toolbox v3.1 K071503, Emory Cardiac Toolbox v2.0 K992450 (PERFEX), COR Analyzer developed by Rcadia K110071, CORRIDOR 4DM V2010 developed by INVIA K101279, and Coronary Flow Reserve (CFR) Quantification (cfrQuant) devel… | 2011 |
| * | K101279 | CORRIDOR4DM V2010 Model: V2010Summary page 1…diac Toolbox v3.1 K071503, Emory Cardiac Toolbox v2.0 K992450 (PERFEX), COR Analyzer developed by Rcadia K110071, CORRIDOR 4DM V2010 developed by INVIA K101279, and Coronary Flow Reserve (CFR) Quantification (cfrQuant) developed by University of Texas Medical School at H… | 2010 |
| * | K113754 | CFR QuantSummary page 1…V2010 developed by INVIA K101279, and Coronary Flow Reserve (CFR) Quantification (cfrQuant) developed by University of Texas Medical School at Houston K113754. 4. Device Description: Nuclear is evolving. We're evolving with you. vwwsynered4Rm… | 2012 |
| † | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | 2002 |
What descends from it? (3)
2 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.
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 3 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 15 of the 63 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K231731 (Mcgovern Medical School, 2023) has gone furthest, with 1 descendant of its own.
- 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 ToolboxTM 4.0 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 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 mechanical dyssynchrony using phase analysis…
Read the full statement (158 words)
The Emory Cardiac ToolboxTM 4.0 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 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 mechanical dyssynchrony using phase analysis, 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), for the quantification of myocardial blood flow and coronary flow reserve, and for the decision support in interpretation (LVX) and automatic structured reporting of the study.
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 as stated in the FDA summary.
https://510kreport.com/device/K123646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123646: Emory Cardiac Toolbox 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123646
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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