510(k) · Cleared
ClearedAdded Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
University of Texas Medical School AT Houston, Texas · KPS System, Tomography, Computed, Emission
Cleared on Sep 22, 2017 as substantially equivalent to K143664 (University of Texas Medical School AT Houston, 2015) after a 142-day review. Its family tree reaches back 9 generations to 1991. 1 of the 41 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Sep 22, 2017
- Review
- 142 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K913770 (1991). 35 ancestors in all, the oldest K892358 (1989). 5 later devices descend from it, 3 citing it directly. 1 of the 41 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations between
- 3 generations backK101279 CORRIDOR4DM V2010 Model: V2010Invia · 2010
- 2 generations backK113754 CFR QuantUniversity of Texas Medical School AT Houston · 2012
- 1 generation backK143664 HeartSeeUniversity of Texas Medical School AT Houston · 2015
- This deviceK171303 Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T…University of Texas Medical School AT Houston, Texas · 2017
- Descendant · cites it directly · 2 of its ownK202679 Optional Screen Display for HeartSee Cardiac P.E.T. Processing…Mcgovern Medical School · 2021
- 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 · cites it directly · 0 of its ownK192277 CardIQ FlowGE Medical Systems SCS · 2020
- Descendant · cites it directly · 0 of its ownK181343 HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 7 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 6 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 5 generations backK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- 4 generations backK083327 Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc. · 2009
- 3 generations backK101279 CORRIDOR4DM V2010 Model: V2010Invia · 2010
- 2 generations backK113754 CFR QuantUniversity of Texas Medical School AT Houston · 2012
- 1 generation backK143664 HeartSeeUniversity of Texas Medical School AT Houston · 2015
- This deviceK171303 Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T…University of Texas Medical School AT Houston, Texas · 2017
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…5 generations back · 1999
Most influential descendants
Showing 5 of 5 · See all- K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School · 2021 · cites it directly2descendants
- 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
- K192277CardIQ FlowGE Medical Systems SCS · 2020 · cites it directly0descendants
- K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −8 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −7 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −6 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −5 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| −4 | K083327 | Syngocirculation Dynamicpet, Version 1.0 | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −3 | K101279 | CORRIDOR4DM V2010 Model: V2010 | Invia | 2010 | — |
| −2 | K113754 | CFR Quant | University of Texas Medical School AT Houston | 2012 | — |
| −1 | K143664 | HeartSee | University of Texas Medical School AT Houston | 2015 | — |
| 0 (this device) | K171303 | Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing… | University of Texas Medical School AT Houston, Texas | 2017 | — |
| +1 | K202679 | Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software -… | Mcgovern Medical School | 2021 | — |
| +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 | — |
| +1 | K192277 | CardIQ Flow | GE Medical Systems SCS | 2020 | — |
| +1 | K181343 | HeartSee Cardiac P.E.T. Processing Software | Bracco Diagnostics, Inc. | 2018 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K143664 | HeartSeeSummary page 4…Regulation name: Emission computed tomography system. Regulation number: 21 CFR 892.1200. Regulatory code: Class II. Product Code: KPS. Devices claimed for equivalence: K143664 Device description: HeartSee K171303 is a software tool for cardiac positron emission tomography (PET) for determining regional… | 2015 |
What descends from it? (5)
3 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 · 5 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 8 of the 35 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K202679 (Mcgovern Medical School, 2021) has gone furthest, with 2 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. 2017, 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?
HeartSee K171303 Software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images by quantification of their severity. HeartSee K171303 is…
Read the full statement (113 words)
HeartSee K171303 Software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images by quantification of their severity.
HeartSee K171303 is intended for use by trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. The clinician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of PET images or quantitative data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171303: Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171303
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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