FDA 510(k)

Sistema de Software de Imagiologia Médica Avançada (KSWVWR)

Número K: K160334 · 2016-06-21

Data da decisão2016-06-21

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Advanced Medical Imaging Software Suite (KSWVWR) is the device name listed in this FDA 510(k) record. The listed applicant is Keosys Sas. It received FDA 510(k) clearance on 2016-06-21 under 510(k) number K160334. 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 Advanced Medical Imaging Software Suite (KSWVWR)?

Advanced Medical Imaging Software Suite (KSWVWR) is a medical device that received FDA 510(k) clearance on 2016-06-21. The listed applicant is Keosys Sas. The 510(k) number is K160334.

When did Advanced Medical Imaging Software Suite (KSWVWR) receive FDA 510(k) clearance?

Advanced Medical Imaging Software Suite (KSWVWR) received FDA 510(k) clearance on 2016-06-21, under 510(k) number K160334.

Who is the listed applicant for Advanced Medical Imaging Software Suite (KSWVWR)?

The FDA 510(k) record lists Keosys Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advanced Medical Imaging Software Suite (KSWVWR)?

The FDA product code for Advanced Medical Imaging Software Suite (KSWVWR) is LLZ.

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