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FDA 510(k)

iLoop Interventional Coil 0.55T

K-Number: K241069 · 2024-06-07

ApplicantNoras Mri Products GmbH
Decision Date2024-06-07
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

iLoop Interventional Coil 0.55T 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 2024-06-07 under 510(k) number K241069. 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 iLoop Interventional Coil 0.55T?

iLoop Interventional Coil 0.55T is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is Noras Mri Products GmbH. The 510(k) number is K241069.

When did iLoop Interventional Coil 0.55T receive FDA 510(k) clearance?

iLoop Interventional Coil 0.55T received FDA 510(k) clearance on 2024-06-07, under 510(k) number K241069.

Who is the listed applicant for iLoop Interventional Coil 0.55T?

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 iLoop Interventional Coil 0.55T?

The FDA product code for iLoop Interventional Coil 0.55T 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.

K220144Breast 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 3TK180123Breast BI 7 MR Coil 1.5T Mammavention

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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