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FDA 510(k)

Breast BI 7 MR Coil 1.5T Mammavention

K-Number: K180123 · 2018-02-16

ApplicantNoras Mri Products GmbH
Decision Date2018-02-16
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Breast BI 7 MR Coil 1.5T Mammavention is a medical device manufactured by Noras Mri Products GmbH. It received FDA 510(k) clearance on 2018-02-16 under approval number K180123. 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 1.5T Mammavention?

Breast BI 7 MR Coil 1.5T Mammavention is a medical device that received FDA 510(k) clearance on 2018-02-16. It is manufactured by Noras Mri Products GmbH. The 510(k) number is K180123.

When was Breast BI 7 MR Coil 1.5T Mammavention approved by the FDA?

Breast BI 7 MR Coil 1.5T Mammavention received FDA 510(k) clearance on 2018-02-16, under approval number K180123.

What company makes Breast BI 7 MR Coil 1.5T Mammavention?

Breast BI 7 MR Coil 1.5T Mammavention is manufactured by Noras Mri Products GmbH.

What is the FDA product code for Breast BI 7 MR Coil 1.5T Mammavention?

The FDA product code for Breast BI 7 MR Coil 1.5T Mammavention is MOS.

Other Devices by Noras Mri Products GmbH

K220144Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T K211658OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T K241069iLoop Interventional Coil 0.55T

Related Devices (Code: MOS)

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Official Source

View on FDA Database →

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

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