510(k) · Cleared
ClearedHeartSee Cardiac P.E.T. Processing Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bracco Diagnostics, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Jun 12, 2018 as substantially equivalent to K171303 (University of Texas Medical School AT Houston, Texas, 2017) after a 22-day review. Its family tree reaches back 10 generations to 1991. 1 of the 37 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 12, 2018
- Review
- 22 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K913770 (1991). 36 ancestors in all, the oldest K892358 (1989). No later device cites it as a predicate yet. 1 of the 37 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK113754 CFR QuantUniversity of Texas Medical School AT Houston · 2012
- 2 generations backK143664 HeartSeeUniversity of Texas Medical School AT Houston · 2015
- 1 generation backK171303 Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T…University of Texas Medical School AT Houston, Texas · 2017
- This deviceK181343 HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc. · 2018
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 8 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 7 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 6 generations backK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- 5 generations backK083327 Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc. · 2009
- 4 generations backK101279 CORRIDOR4DM V2010 Model: V2010Invia · 2010
- 3 generations backK113754 CFR QuantUniversity of Texas Medical School AT Houston · 2012
- 2 generations backK143664 HeartSeeUniversity of Texas Medical School AT Houston · 2015
- 1 generation backK171303 Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T…University of Texas Medical School AT Houston, Texas · 2017
- This deviceK181343 HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc. · 2018
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…6 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −8 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −7 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −6 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| −5 | K083327 | Syngocirculation Dynamicpet, Version 1.0 | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −4 | K101279 | CORRIDOR4DM V2010 Model: V2010 | Invia | 2010 | — |
| −3 | K113754 | CFR Quant | University of Texas Medical School AT Houston | 2012 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K171303 | Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664Summary page 4…n computed tomography system. Classification Regulation: 21 CFR 892.1200 (Class II) Product Code: KPS PREDICATE DEVICE e HeartSee Cardiac P.E.T. Processing Software (K171303) DEeviCE DESCRIPTION HeartSee is a software tool for cardiac positron emission tomography (PET) for determining regional and gl… | 2017 |
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 · 6 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 8 of the 36 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K171303.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 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 is intended for use…
Read the full statement (111 words)
HeartSee 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181343: HeartSee Cardiac P.E.T. Processing Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181343
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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