FDA 510(k)

0.55T 12Ch Bobina de Peito

Número K: K260947 · 2026-04-23

Data da decisão2026-04-23

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

0.55T 12Ch Breast Coil is the device name listed in this FDA 510(k) record. The listed applicant is Neocoil, LLC. It received FDA 510(k) clearance on 2026-04-23 under 510(k) number K260947. 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 0.55T 12Ch Breast Coil?

0.55T 12Ch Breast Coil is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is Neocoil, LLC. The 510(k) number is K260947.

When did 0.55T 12Ch Breast Coil receive FDA 510(k) clearance?

0.55T 12Ch Breast Coil received FDA 510(k) clearance on 2026-04-23, under 510(k) number K260947.

Who is the listed applicant for 0.55T 12Ch Breast Coil?

The FDA 510(k) record lists Neocoil, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 0.55T 12Ch Breast Coil?

The FDA product code for 0.55T 12Ch Breast Coil is MOS.

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Outros registros que listam Neocoil, LLC como candidato(a)

K22240716ch Bobina de Mama / 16ch Bobinas de Mama, 1.5T 16ch Bobina de Mama, 3.0T 16ch Bobina de Mama, 1.5T 16ch Bobina de Mama, 3T 16ch Bobina de Mama K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch K2011011.5T 16ch Braço de Cisalhamento de Ombro, 3.0T 16ch Braço de Cisalhamento de Ombro K1829581.5T 16ch Braço de Cisalhamento de Peito K173409Wireless Audio System K1733773.0T 16ch Breast Coil

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Dispositivos Relacionados (Código: MOS)

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Fonte oficial

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