FDA 510(k)

HeartSee Cardiac P.E.T. Processing Software

Número K: K181343 · 2018-06-12

Data da decisão2018-06-12

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

HeartSee Cardiac P.E.T. Processing Software 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 2018-06-12 under 510(k) number K181343. 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?

HeartSee Cardiac P.E.T. Processing Software is a medical device that received FDA 510(k) clearance on 2018-06-12. The listed applicant is Bracco Diagnostics, Inc.. The 510(k) number is K181343.

When did HeartSee Cardiac P.E.T. Processing Software receive FDA 510(k) clearance?

HeartSee Cardiac P.E.T. Processing Software received FDA 510(k) clearance on 2018-06-12, under 510(k) number K181343.

Who is the listed applicant for HeartSee Cardiac P.E.T. Processing Software?

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?

The FDA product code for HeartSee Cardiac P.E.T. Processing Software is KPS.

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

K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4

Dispositivos Relacionados (Código: KPS)

Fonte oficial

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