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FDA 510(k)

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

K-Number: K243881 · 2025-03-03

ApplicantBracco Diagnostics, Inc.
Decision Date2025-03-03
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 is a medical device manufactured by Bracco Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-03-03 under approval number K243881. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 is a medical device that received FDA 510(k) clearance on 2025-03-03. It is manufactured by Bracco Diagnostics, Inc.. The 510(k) number is K243881.

When was HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 approved by the FDA?

HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 received FDA 510(k) clearance on 2025-03-03, under approval number K243881.

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

HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 is manufactured by Bracco Diagnostics, Inc..

What is the FDA product code for HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4?

The FDA product code for HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 is KPS.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT07108231 Inspiratory Muscle Training in Hospitalized Heart Failure Patients RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT01220349 Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy COMPLETED NCT06353594 Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI RECRUITING

Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025)

Other Devices by Bracco Diagnostics, Inc.

K181343HeartSee Cardiac P.E.T. Processing Software

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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