FDA 510(k)

Proton Positioing and Immobilization Devices

Número K: K180021 · 2018-06-29

RequerenteMedtec Inc Dba Civco Medical Solutions and Civco Radiotherap

Data da decisão2018-06-29

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Proton Positioing and Immobilization Devices is the device name listed in this FDA 510(k) record. The listed applicant is Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap. It received FDA 510(k) clearance on 2018-06-29 under 510(k) number K180021. 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 Proton Positioing and Immobilization Devices?

Proton Positioing and Immobilization Devices is a medical device that received FDA 510(k) clearance on 2018-06-29. The listed applicant is Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap. The 510(k) number is K180021.

When did Proton Positioing and Immobilization Devices receive FDA 510(k) clearance?

Proton Positioing and Immobilization Devices received FDA 510(k) clearance on 2018-06-29, under 510(k) number K180021.

Who is the listed applicant for Proton Positioing and Immobilization Devices?

The FDA 510(k) record lists Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Proton Positioing and Immobilization Devices?

The FDA product code for Proton Positioing and Immobilization Devices is IYE.

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