# K243881: HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4

- Pathway: 510(k) (Traditional)
- Applicant: Bracco Diagnostics, Inc.
- Decided: Mar 3, 2025 after 75 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: 14 generations back to K913770 (1991). 70 ancestors in all.
No later device cites it as a predicate yet.
1 of 71 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231731: Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4, Mcgovern Medical School (2023) Summary page 5.

## Indications for use
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 and 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.

Source page: https://510kreport.com/device/K243881
Methodology: https://510kreport.com/methodology