FDA 510(k)

Breast BI 7 MR Coil Mammavention 3T

K-Number: K162651 · 2017-01-18

Decision Date2017-01-18

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Moras Mri Products GmbH. The 510(k) number is K162651.

When was Breast BI 7 MR Coil Mammavention 3T approved by the FDA?

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

What company makes Breast BI 7 MR Coil Mammavention 3T?

Breast BI 7 MR Coil Mammavention 3T is manufactured by Moras Mri Products GmbH.

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.