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

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 the device name listed in this FDA 510(k) record. The listed applicant is Bracco Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-03-03 under 510(k) 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. The listed applicant is Bracco Diagnostics, Inc.. The 510(k) number is K243881.

When did HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 receive FDA 510(k) clearance?

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 510(k) number K243881.

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

The FDA 510(k) record lists Bracco Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07763769Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)COMPLETED NCT07548281Intravascular Ultrasound- and Angiography-Derived Fractional Flow Reserve-Guided Drug-Coated Balloon for Large Coronary Artery De Novo LesionsNOT_YET_RECRUITING NCT05102019Efficacy of the COronary SInus Reducer in Patients With Refractory Angina IIRECRUITING NCT05632614Blood Flow Reserve: Effects After Training With Heavy Inspiratory ExercisesCOMPLETED NCT06977295Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)RECRUITING NCT07514624CRIC Combined With MFT for MFR in Patients With Incomplete Revascularization of CADNOT_YET_RECRUITING

Other records listing Bracco Diagnostics, Inc. as applicant

K181343HeartSee Cardiac P.E.T. Processing Software

Related Devices (Code: KPS)

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.