# K143664: HeartSee

- Pathway: 510(k) (Traditional)
- Applicant: University of Texas Medical School AT Houston
- Decided: Apr 14, 2015 after 112 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: 8 generations back to K913770 (1991). 34 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K090178: Attrius, Model PET150A6001, Attrius L, Model PET150A8001, Truesight, Model NSP-P6C, Truesight, Model NSP-P8, Neusoft Positron Medical Systems Co., Ltd. (2009) Summary page 4.
- K113754: CFR Quant, University of Texas Medical School AT Houston (2012) Summary page 4.

## Most influential descendants
- K171303: Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 (2017), 5 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
- K243881: HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 (2025), 0 descendants of its own
- K192277: CardIQ Flow (2020), 0 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K143664
Methodology: https://510kreport.com/methodology