# Bracco Diagnostics, Inc.

- Location (FDA's records): Monroe Township, NE
- FDA decisions: 2 (2018–2025): 2 510(k) clearances
- Product codes: KPS (2)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- University of Texas Medical School AT Houston, Texas: 1 (https://510kreport.com/company/university-of-texas-medical-school-at-houston-texas)
- Mcgovern Medical School: 1 (https://510kreport.com/company/mcgovern-medical-school)

## Recent decisions
- K243881: HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 (Mar 3, 2025)
- K181343: HeartSee Cardiac P.E.T. Processing Software (Jun 12, 2018)

Source page: https://510kreport.com/company/bracco-diagnostics