FDA 510(k)

i-CAT FLX V series / KaVo 3D eXam+ V series

Número K: K162085 · 2016-11-10

RequerenteImaging Sciences International

Data da decisão2016-11-10

Código do produtoOAS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

i-CAT FLX V series / KaVo 3D eXam+ V series is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Sciences International. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K162085. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the i-CAT FLX V series / KaVo 3D eXam+ V series?

i-CAT FLX V series / KaVo 3D eXam+ V series is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Imaging Sciences International. The 510(k) number is K162085.

When did i-CAT FLX V series / KaVo 3D eXam+ V series receive FDA 510(k) clearance?

i-CAT FLX V series / KaVo 3D eXam+ V series received FDA 510(k) clearance on 2016-11-10, under 510(k) number K162085.

Who is the listed applicant for i-CAT FLX V series / KaVo 3D eXam+ V series?

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

What is the FDA product code for i-CAT FLX V series / KaVo 3D eXam+ V series?

The FDA product code for i-CAT FLX V series / KaVo 3D eXam+ V series is OAS.

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