# K113754: CFR Quant

- Pathway: 510(k) (Traditional)
- Applicant: University of Texas Medical School AT Houston
- Decided: Jul 19, 2012 after 211 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K913770 (1991). 31 ancestors in all.
9 later devices descend from it; 2 cite it directly.
1 of 41 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101279: CORRIDOR4DM V2010 Model: V2010, Invia (2010) Summary page 1.
- K083327: Syngocirculation Dynamicpet, Version 1.0, Siemens Medical Solutions USA, Inc. (2009) Summary page 1.
- K080770: Imagenmd with Imagenq, Cardiovascular Imaging Technologies, LLC (2008) Summary page 1.

## Most influential descendants
- K143664: HeartSee (2015), 6 descendants of its own
- K171303: Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 (2017), 5 descendants of its own
- K123646: Emory Cardiac Toolbox 4.0 (2013), 3 descendants of its own
- K202679: Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 (2021), 2 descendants of its own
- K231731: Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 (2023), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K113754
Methodology: https://510kreport.com/methodology