510(k) · Cleared
ClearedEmory Cardiac Toolbox 4.3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntermed · KPS System, Tomography, Computed, Emission
Cleared on Mar 30, 2023 as substantially equivalent to K123646 (Syntermed, Inc., 2013) and 2 other predicates after a 136-day review. Its family tree reaches back 19 generations to 1995. 1 of the 216 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 30, 2023
- Review
- 136 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K935595 (1995). 215 ancestors in all, the oldest K892358 (1989). No later device cites it as a predicate yet. 1 of the 216 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations between
- 3 generations backK191647 QLAB Advanced Quantification SoftwarePhilips Health Care · 2019
- 2 generations backK200974 QLAB Advanced Quantification SoftwarePhilips Health Care · 2020
- 1 generation backK201632 Tomtec-ArenaTomtec Imaging Systems GmbH · 2020
- This deviceK223422 Emory Cardiac Toolbox 4.3Syntermed · 2023
Show all 19 generations
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 17 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 16 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 15 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 14 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 13 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 12 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 10 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 9 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 8 generations backK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- 7 generations backK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- 6 generations backK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- 5 generations backK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
- 4 generations backK181264 QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018
- 3 generations backK191647 QLAB Advanced Quantification SoftwarePhilips Health Care · 2019
- 2 generations backK200974 QLAB Advanced Quantification SoftwarePhilips Health Care · 2020
- 1 generation backK201632 Tomtec-ArenaTomtec Imaging Systems GmbH · 2020
- This deviceK223422 Emory Cardiac Toolbox 4.3Syntermed · 2023
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…4 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −18 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −17 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −16 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −15 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −14 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −13 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −12 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −10 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −9 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −8 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −7 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| −6 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
| −5 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | — |
| −4 | K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | 2018 | — |
| −3 | K191647 | QLAB Advanced Quantification Software | Philips Health Care | 2019 | — |
| −2 | K200974 | QLAB Advanced Quantification Software | Philips Health Care | 2020 | — |
| −1 | K201632 | Tomtec-Arena | Tomtec Imaging Systems GmbH | 2020 | — |
| 0 (this device) | K223422 | Emory Cardiac Toolbox 4.3 | Syntermed | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 10 | 0 |
| 1995 | 12 | 0 |
| 1996 | 11 | 0 |
| 1997 | 12 | 0 |
| 1998 | 10 | 0 |
| 1999 | 17 | 1 |
| 2000 | 13 | 0 |
| 2001 | 11 | 0 |
| 2002 | 17 | 0 |
| 2003 | 6 | 0 |
| 2004 | 18 | 0 |
| 2005 | 7 | 0 |
| 2006 | 7 | 0 |
| 2007 | 9 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 18.7 · 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? (3)
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 |
|---|---|---|---|
| * | K123646 | Emory Cardiac Toolbox 4.0Summary page 4…21 CFR 892.2050 Product Code: KPS, JAK, and LLZ Classification Panel: Radiology Device Class: Class II 3. Medical Device Equivalence: Emory Cardiac Toolbox 4.0 K123646 Syngo.CT Ca Scoring developed by Siemens Medical Solutions USA, Inc. K201034 TOMTEC-Arena (AutoStrain Suite)… | 2013 |
| * | K201034 | Syngo.CT CaScoringSummary page 4…s: Class II 3. Medical Device Equivalence: Emory Cardiac Toolbox 4.0 K123646 Syngo.CT Ca Scoring developed by Siemens Medical Solutions USA, Inc. K201034 TOMTEC-Arena (AutoStrain Suite) developed by TOMTEC Imaging Systems GmbH K201632. 4. Device Description: The Emor… | 2020 |
| * | K201632 | Tomtec-ArenaSummary page 4…yngo.CT Ca Scoring developed by Siemens Medical Solutions USA, Inc. K201034 TOMTEC-Arena (AutoStrain Suite) developed by TOMTEC Imaging Systems GmbH K201632. 4. Device Description: The Emory Cardiac Toolbox™ 4.3 is used to display gated wall motion and for quantifying parameters of l… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 4 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 44 of the 215 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K123646.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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™ 4.0 – 4.3 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 (EGS™) including to quantitatively evaluate the wall motion and wall thickening of the heart using longitudinal, radial, and circumferential strain measurements, for the 3D alignment of coronary artery…
Read the full statement (153 words)
The Emory Cardiac Toolbox™ 4.0 – 4.3 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 (EGS™) including to quantitatively
evaluate the wall motion and wall thickening of the heart using longitudinal, radial, and circumferential
strain measurements, for the 3D alignment of coronary artery models from CT coronary angiography
onto the left ventricular 3D epicardial surface and analysis of the CT data to evaluate calcified plaques
in the coronary arteries, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223422 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223422: Emory Cardiac Toolbox 4.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223422
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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