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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 a medical device manufactured by Noras Mri Products GmbH. It received FDA 510(k) clearance on 2024-06-07 under approval 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. It is manufactured by Noras Mri Products GmbH. The 510(k) number is K241069.

When was iLoop Interventional Coil 0.55T approved by the FDA?

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

What company makes iLoop Interventional Coil 0.55T?

iLoop Interventional Coil 0.55T is manufactured by Noras Mri Products GmbH.

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 Devices by Noras Mri Products GmbH

K180123Breast BI 7 MR Coil 1.5T Mammavention 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

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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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