FDA 510(k)

AIRO Tomografia Computadorizada (CT) de Raios X

Número K: K180393 · 2018-03-15

Data da decisão2018-03-15

Código do produtoJAK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

AIRO Computed Tomography (CT) X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Mobius Imaging, LLC. It received FDA 510(k) clearance on 2018-03-15 under 510(k) number K180393. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AIRO Computed Tomography (CT) X-ray System?

AIRO Computed Tomography (CT) X-ray System is a medical device that received FDA 510(k) clearance on 2018-03-15. The listed applicant is Mobius Imaging, LLC. The 510(k) number is K180393.

When did AIRO Computed Tomography (CT) X-ray System receive FDA 510(k) clearance?

AIRO Computed Tomography (CT) X-ray System received FDA 510(k) clearance on 2018-03-15, under 510(k) number K180393.

Who is the listed applicant for AIRO Computed Tomography (CT) X-ray System?

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

What is the FDA product code for AIRO Computed Tomography (CT) X-ray System?

The FDA product code for AIRO Computed Tomography (CT) X-ray System is JAK.

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