510(k) · Cleared
ClearedHeartSee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
University of Texas Medical School AT Houston · KPS System, Tomography, Computed, Emission
Cleared on Apr 14, 2015 as substantially equivalent to K090178 (Neusoft Positron Medical Systems Co., Ltd., 2009) and 1 other predicate after a 112-day review. Its family tree reaches back 8 generations to 1991. 1 of the 41 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Apr 14, 2015
- Review
- 112 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K913770 (1991). 34 ancestors in all, the oldest K892358 (1989). 6 later devices descend from it, 1 citing it directly. 1 of the 41 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 6 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 5 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 4 generations backK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- 3 generations backK083327 Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc. · 2009
- 2 generations backK101279 CORRIDOR4DM V2010 Model: V2010Invia · 2010
- 1 generation backK113754 CFR QuantUniversity of Texas Medical School AT Houston · 2012
- This deviceK143664 HeartSeeUniversity of Texas Medical School AT Houston · 2015
- Descendant · cites it directly · 5 of its ownK171303 Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T…University of Texas Medical School AT Houston, Texas · 2017
- Descendant · 2 generations on · 2 of its ownK202679 Optional Screen Display for HeartSee Cardiac P.E.T. Processing…Mcgovern Medical School · 2021
- Descendant · 3 generations on · 1 of its ownK231731 Optional Screen Displays for HeartSee Cardiac P.E.T. Processing…Mcgovern Medical School · 2023
- Descendant · 4 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 ownK192277 CardIQ FlowGE Medical Systems SCS · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…4 generations back · 1999
Most influential descendants
Showing 5 of 6 · See all- K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas · 2017 · cites it directly5descendants
- K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School · 2021 · 2 generations on2descendants
- K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School · 2023 · 3 generations on1descendant
- K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc. · 2025 · 4 generations on0descendants
- K192277CardIQ FlowGE Medical Systems SCS · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −7 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −6 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −5 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −4 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| −3 | K083327 | Syngocirculation Dynamicpet, Version 1.0 | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −2 | K101279 | CORRIDOR4DM V2010 Model: V2010 | Invia | 2010 | — |
| −1 | K113754 | CFR Quant | University of Texas Medical School AT Houston | 2012 | — |
| 0 (this device) | K143664 | HeartSee | University of Texas Medical School AT Houston | 2015 | — |
| +1 | K171303 | Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing… | University of Texas Medical School AT Houston, Texas | 2017 | — |
| +2 | K202679 | Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software -… | Mcgovern Medical School | 2021 | — |
| +3 | K231731 | Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software -… | Mcgovern Medical School | 2023 | — |
| +4 | K243881 | HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and… | Bracco Diagnostics, Inc. | 2025 | — |
| +2 | K192277 | CardIQ Flow | GE Medical Systems SCS | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 1 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K090178 | Attrius, Model PET150A6001, Attrius L, Model PET150A8001, Truesight, Model NSP-P6C…Summary page 4…n Tomography (PET) Analysis Software Classification names: emission computed tomography system (21 CFR 892.1200, Product Code KPS) Devices claimed for equivalence: • K090178, NeuSoft Positron Attrius scanner (CARDIAC software component) • K113754, cfrQuant General description: The cardiac pos… | 2009 |
| * | K113754 | CFR QuantSummary page 4…graphy system (21 CFR 892.1200, Product Code KPS) Devices claimed for equivalence: • K090178, NeuSoft Positron Attrius scanner (CARDIAC software component) • K113754, cfrQuant General description: The cardiac positron emission tomography (PET) analysis tool HeartSee is a software package inten… | 2012 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171303 | Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 | 2017 | 5 |
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 24 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 8 of the 34 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K171303 (University of Texas Medical School AT Houston, Texas, 2017) has gone furthest, with 5 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. 2015, 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 cardiac positron emission tomography (PET) analysis tool, HeartSee is a software package intended for use by nuclear medicine and nuclear cardiology physicians and technologists to facilitate image interpretation. Archiving of output data will be supported for clinical diagnostics, quality control, and research. HeartSee contain two fundamental components. First, the software can import cardiac PET images in DICOM format from any PET camera from any…
Read the full statement (127 words)
The cardiac positron emission tomography (PET) analysis tool, HeartSee is a software package intended for use by
nuclear medicine and nuclear cardiology physicians and technologists to facilitate image interpretation. Archiving of
output data will be supported for clinical diagnostics, quality control, and research.
HeartSee contain two fundamental components. First, the software can import cardiac PET images in DICOM format from
any PET camera from any camera manufacturer. These images can be reoriented to cardiac axes to produce standard
tomographic and topographic displays of relative uptake. A trained, licensed physician can interpret these processed images
as per standard practice.
Second, the CFR software can quantify absolute myocardial blood flow per unit tissue (cc/min/gm) in stress and rest
PET cardiac images and quantitatively assess the coronary flow reserve (CFR).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143664: HeartSee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143664
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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