FDA 510(k)

iQMR

Número K: K173605 · 2018-03-08

RequerenteMedic Vision - Imaging Solutions, Ltd.

Data da decisão2018-03-08

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

iQMR is the device name listed in this FDA 510(k) record. The listed applicant is Medic Vision - Imaging Solutions, Ltd.. It received FDA 510(k) clearance on 2018-03-08 under 510(k) number K173605. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the iQMR?

iQMR is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Medic Vision - Imaging Solutions, Ltd.. The 510(k) number is K173605.

When did iQMR receive FDA 510(k) clearance?

iQMR received FDA 510(k) clearance on 2018-03-08, under 510(k) number K173605.

Who is the listed applicant for iQMR?

The FDA 510(k) record lists Medic Vision - Imaging Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iQMR?

The FDA product code for iQMR is LLZ.

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