FDA 510(k)

iLoop Interventional Coil 0.55T

Número K: K241069 · 2024-06-07

Data da decisão2024-06-07

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Noras Mri Products GmbH como candidato(a)

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 K180123Breast BI 7 MR Coil 1.5T Mammavention

Dispositivos Relacionados (Código: MOS)

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