FDA 510(k)

I4 (Integrated Intelligent Imaging Informatics) system

Número K: K160315 · 2016-02-19

RequerentePhilips Medical Systems Nederland B.V.

Data da decisão2016-02-19

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

I4 (Integrated Intelligent Imaging Informatics) system is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K160315. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the I4 (Integrated Intelligent Imaging Informatics) system?

I4 (Integrated Intelligent Imaging Informatics) system is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K160315.

When did I4 (Integrated Intelligent Imaging Informatics) system receive FDA 510(k) clearance?

I4 (Integrated Intelligent Imaging Informatics) system received FDA 510(k) clearance on 2016-02-19, under 510(k) number K160315.

Who is the listed applicant for I4 (Integrated Intelligent Imaging Informatics) system?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I4 (Integrated Intelligent Imaging Informatics) system?

The FDA product code for I4 (Integrated Intelligent Imaging Informatics) system is LLZ.

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