HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4— 510(k) K243881
Substantially EquivalentBracco Diagnostics, Inc.
FDA 510(k) clearance K243881 for HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4, Substantially Equivalent on 2025-03-03. Applicant: Bracco Diagnostics, Inc..
Clearance details
- Applicant
- Bracco Diagnostics, Inc.
- Product code
- Code KPS
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Princeton, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.