HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4— 510(k) K243881

Name: FDA 510(k) clearance K243881
Creator: U.S. Food and Drug Administration
Published: 2025-03-03

Substantially Equivalent

Bracco 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.. Device class: 2.

Clearance details

Applicant: Bracco Diagnostics, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2024-12-18
Decision date: 2025-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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