FDA 510(k)

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)

Número K: K161724 · 2017-04-28

Data da decisão2017-04-28

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) is the device name listed in this FDA 510(k) record. The listed applicant is Radiomed Corporation. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K161724. 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 Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)?

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Radiomed Corporation. The 510(k) number is K161724.

When did Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) receive FDA 510(k) clearance?

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) received FDA 510(k) clearance on 2017-04-28, under 510(k) number K161724.

Who is the listed applicant for Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)?

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

What is the FDA product code for Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)?

The FDA product code for Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) is IYE.

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