FDA 510(k)

Biograph Horizon PET/CT

Número K: K152880 · 2016-01-12

RequerenteSiemens Medical Solutions USA, Inc.

Data da decisão2016-01-12

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Biograph Horizon PET/CT is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-01-12 under 510(k) number K152880. 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 Biograph Horizon PET/CT?

Biograph Horizon PET/CT is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K152880.

When did Biograph Horizon PET/CT receive FDA 510(k) clearance?

Biograph Horizon PET/CT received FDA 510(k) clearance on 2016-01-12, under 510(k) number K152880.

Who is the listed applicant for Biograph Horizon PET/CT?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biograph Horizon PET/CT?

The FDA product code for Biograph Horizon PET/CT is KPS.

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