FDA 510(k)

Breast BI 7 MR Coil Mammavention 3T

Número K: K162651 · 2017-01-18

Data da decisão2017-01-18

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Breast BI 7 MR Coil Mammavention 3T is the device name listed in this FDA 510(k) record. The listed applicant is Moras Mri Products GmbH. It received FDA 510(k) clearance on 2017-01-18 under 510(k) number K162651. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Breast BI 7 MR Coil Mammavention 3T?

Breast BI 7 MR Coil Mammavention 3T is a medical device that received FDA 510(k) clearance on 2017-01-18. The listed applicant is Moras Mri Products GmbH. The 510(k) number is K162651.

When did Breast BI 7 MR Coil Mammavention 3T receive FDA 510(k) clearance?

Breast BI 7 MR Coil Mammavention 3T received FDA 510(k) clearance on 2017-01-18, under 510(k) number K162651.

Who is the listed applicant for Breast BI 7 MR Coil Mammavention 3T?

The FDA 510(k) record lists Moras Mri Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Breast BI 7 MR Coil Mammavention 3T?

The FDA product code for Breast BI 7 MR Coil Mammavention 3T is MOS.

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