FDA 510(k)

Aurora-RT

Número K: K213526 · 2022-05-04

RequerenteMagnettx Oncology Solutions , Ltd.

Data da decisão2022-05-04

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aurora-RT is the device name listed in this FDA 510(k) record. The listed applicant is Magnettx Oncology Solutions , Ltd.. It received FDA 510(k) clearance on 2022-05-04 under 510(k) number K213526. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aurora-RT?

Aurora-RT is a medical device that received FDA 510(k) clearance on 2022-05-04. The listed applicant is Magnettx Oncology Solutions , Ltd.. The 510(k) number is K213526.

When did Aurora-RT receive FDA 510(k) clearance?

Aurora-RT received FDA 510(k) clearance on 2022-05-04, under 510(k) number K213526.

Who is the listed applicant for Aurora-RT?

The FDA 510(k) record lists Magnettx Oncology Solutions , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aurora-RT?

The FDA product code for Aurora-RT is IYE.

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