Bracco Diagnostics, Inc. · Class II · Cleared Mar 3, 2025
| K-number | K243881 |
| Device name | HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 |
| Applicant | Bracco Diagnostics, Inc. |
| Product code | KPS |
| Device class | Class II |
| Decision date | Mar 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1200 |
HeartSee is a software tool for analyzing cardiac PET images to measure myocardial perfusion, coronary flow reserve, and coronary flow capacity in patients with suspected or known coronary artery disease. It is intended for use by trained nuclear medicine professionals and cardiologists to assist in the interpretation and quantification of PET perfusion images.
The proposed device migrates the software platform to Windows operating system compared to the predicate, includes minor software application updates, and incorporates cybersecurity enhancements. The underlying code and functionality for quantifying myocardial perfusion, CFR, CFC maps, displays, and left ventricular ejection fraction determination remain essentially identical to the predicate device.
Not stated in this summary.
Because the overall design and core functionality of the proposed device and predicate device K231731 are essentially identical, with only platform migration and cybersecurity updates implemented, the nonclinical testing data from the predicate combined with system and cybersecurity testing of the proposed device is sufficient to establish substantial equivalence. No new types of testing were required since the algorithm and measurement capabilities were not changed.
View the full FDA submission: accessdata.fda.gov