K243881

Substantially Equivalent

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

Applicant: Bracco Diagnostics, Inc.
Product code: KPS
Advisory panel: Radiology
Date received: 2024-12-18
Decision date: 2025-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

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