FDA 510(k)

QSM software, QSMetric

Número K: K210415 · 2021-07-22

Data da decisão2021-07-22

Código do produtoLNH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

QSM software, QSMetric is the device name listed in this FDA 510(k) record. The listed applicant is Medimagemetric, LLC. It received FDA 510(k) clearance on 2021-07-22 under 510(k) number K210415. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the QSM software, QSMetric?

QSM software, QSMetric is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Medimagemetric, LLC. The 510(k) number is K210415.

When did QSM software, QSMetric receive FDA 510(k) clearance?

QSM software, QSMetric received FDA 510(k) clearance on 2021-07-22, under 510(k) number K210415.

Who is the listed applicant for QSM software, QSMetric?

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

What is the FDA product code for QSM software, QSMetric?

The FDA product code for QSM software, QSMetric is LNH.

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