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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 the device name listed in this FDA 510(k) record. The listed applicant is Noras Mri Products GmbH. It received FDA 510(k) clearance on 2018-02-16 under 510(k) 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. The listed applicant is Noras Mri Products GmbH. The 510(k) number is K180123.

When did Breast BI 7 MR Coil 1.5T Mammavention receive FDA 510(k) clearance?

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

Who is the listed applicant for Breast BI 7 MR Coil 1.5T Mammavention?

The FDA 510(k) record lists Noras 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 1.5T Mammavention?

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

Other records listing Noras Mri Products GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241069iLoop Interventional Coil 0.55TK220144Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3TK211658OR 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

Related Devices (Code: MOS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLCK252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

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.

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