FDA 510(k)

RadGil2

Número K: K201177 · 2020-08-17

Data da decisão2020-08-17

Código do produtoMOT

DecisãoSubstantially Equivalent

Resumo do dispositivo

RadGil2 is the device name listed in this FDA 510(k) record. The listed applicant is R3 X-Ray L.L.C. It received FDA 510(k) clearance on 2020-08-17 under 510(k) number K201177. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RadGil2?

RadGil2 is a medical device that received FDA 510(k) clearance on 2020-08-17. The listed applicant is R3 X-Ray L.L.C. The 510(k) number is K201177.

When did RadGil2 receive FDA 510(k) clearance?

RadGil2 received FDA 510(k) clearance on 2020-08-17, under 510(k) number K201177.

Who is the listed applicant for RadGil2?

The FDA 510(k) record lists R3 X-Ray L.L.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RadGil2?

The FDA product code for RadGil2 is MOT.

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