FDA 510(k)

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

Número K: K243881 · 2025-03-03

Data da decisão2025-03-03

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Bracco Diagnostics, Inc. como candidato(a)

K181343HeartSee Cardiac P.E.T. Processing Software

Dispositivos Relacionados (Código: KPS)

Fonte oficial

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