510(k) · Cleared
ClearedCFR Quant
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 Jul 19, 2012 as substantially equivalent to K101279 (Invia, 2010) and 2 other predicates after a 211-day review. Its family tree reaches back 7 generations to 1991. 1 of the 41 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Jul 19, 2012
- Review
- 211 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K913770 (1991). 31 ancestors in all, the oldest K892358 (1989). 9 later devices descend from it, 2 citing it directly. 1 of the 41 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 5 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 4 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 3 generations backK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- 2 generations backK083327 Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc. · 2009
- 1 generation backK101279 CORRIDOR4DM V2010 Model: V2010Invia · 2010
- This deviceK113754 CFR QuantUniversity of Texas Medical School AT Houston · 2012
- Descendant · cites it directly · 6 of its ownK143664 HeartSeeUniversity of Texas Medical School AT Houston · 2015
- Descendant · 2 generations on · 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 · cites it directly · 3 of its ownK123646 Emory Cardiac Toolbox 4.0Syntermed, Inc. · 2013
- Descendant · 3 generations on · 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
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…3 generations back · 1999
Most influential descendants
Showing 5 of 9 · See all- K143664HeartSeeUniversity of Texas Medical School AT Houston · 2015 · cites it directly6descendants
- K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas · 2017 · 2 generations on5descendants
- K123646Emory Cardiac Toolbox 4.0Syntermed, Inc. · 2013 · cites it directly3descendants
- K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School · 2021 · 3 generations on2descendants
- K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −5 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −4 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| −2 | K083327 | Syngocirculation Dynamicpet, Version 1.0 | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K101279 | CORRIDOR4DM V2010 Model: V2010 | Invia | 2010 | — |
| 0 (this device) | K113754 | CFR Quant | University of Texas Medical School AT Houston | 2012 | — |
| +1 | K143664 | HeartSee | University of Texas Medical School AT Houston | 2015 | — |
| +2 | K171303 | Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing… | University of Texas Medical School AT Houston, Texas | 2017 | — |
| +1 | K123646 | Emory Cardiac Toolbox 4.0 | Syntermed, Inc. | 2013 | — |
| +3 | 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 | — |
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 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 18.7 · 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 |
|---|---|---|---|
| * | K101279 | CORRIDOR4DM V2010 Model: V2010Summary page 1…Flow Reserve.(CFR) Quantification Classification names: emission computed tomography system (21 CFIR 892.1200, Product Code KIPS) Devices claimed for equivalence: * K101279, Corridor4DM v2010 * K083327, syngoCirculation DynamicPET * K080770, lmagenMD with lmagenQ General description: The coronary… | 2010 |
| * | K083327 | Syngocirculation Dynamicpet, Version 1.0Summary page 1…ion Classification names: emission computed tomography system (21 CFIR 892.1200, Product Code KIPS) Devices claimed for equivalence: * K101279, Corridor4DM v2010 * K083327, syngoCirculation DynamicPET * K080770, lmagenMD with lmagenQ General description: The coronary flow reserve (CFR) quantificat… | 2009 |
| * | K080770 | Imagenmd with ImagenqSummary page 1…ted tomography system (21 CFIR 892.1200, Product Code KIPS) Devices claimed for equivalence: * K101279, Corridor4DM v2010 * K083327, syngoCirculation DynamicPET * K080770, lmagenMD with lmagenQ General description: The coronary flow reserve (CFR) quantification (cfrQuant) system is a software packa… | 2008 |
What descends from it? (9)
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 21 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 8 of the 31 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K143664 (University of Texas Medical School AT Houston, 2015) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K101279.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 cfrQuant coronary flow reserve (CFR) quantification software quantifies blood flow in the myocardial wall of the heart's left ventricle based on positron emission tomography (PET) images of radionuclide tracer distribution. The product is intended for use by trained professionals, such as nuclear technicians and nuclear medicine or nuclear cardiology physicians. The clinician remains ultimately responsible for the final assessment and diagnosis based…
Read the full statement (152 words)
The cfrQuant coronary flow reserve (CFR) quantification software quantifies
blood flow in the myocardial wall of the heart's left ventricle based on positron
emission tomography (PET) images of radionuclide tracer distribution.
The product is intended for use by trained professionals, such as nuclear
technicians and nuclear medicine or nuclear cardiology physicians. The clinician
remains ultimately responsible for the final assessment and diagnosis based on
standard practices and visual interpretation of all PET data.
The software accepts cardiac PET images of either N-13 ammonia or Rb-82
tracer uptake during two physiologic states: baseline (rest) and increased blood
flow (stress). A mathematical model computes absolute myocardial perfusion
(flow per mass of tissue, or cc/min/gm) at rest and stress. The ratio of stress-to-
rest flow is termed the coronary flow reserve (CFR). Visual displays of absolute
flow and CFR as well as their numeric quantification are presented to aid
diagnostic interpretation of myocardial PET images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113754 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113754: CFR Quant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113754
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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