FDA 510(k)

0.55T 12Ch Bobina de Mama

N.º K: K260947 · 2026-04-23

Fecha de decisión2026-04-23

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Neocoil, LLC como solicitante

K222407Bobina de Seno 16ch / Bobinas de Seno 16ch, Bobina de Seno 16ch 1.5T, Bobina de Seno 16ch 3.0T, Bobina de Seno 16ch 1.5T, Bobina de Seno 16ch 3T K213687Suite de Bobinas ABIERTAS 32Ch AIR: 1.5T ABIERTO Cabeza Cuello Posterior 9ch / 3.0T ABIERTO Cabeza Cuello Posterior 9ch, 1.5T ABIERTO Cuello Pecho Anterior 7ch / 3.0T ABIERTO Cuello Pecho Anterior 7ch, 1.5T ABIERTO Cabeza Anterior 16ch / 3.0T ABIERTO Cabeza Anterior 16ch K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil K1829581.5T 16ch Breast Coil K173409Wireless Audio System K1733773.0T 16ch Breast Coil

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Dispositivos relacionados (Código: MOS)

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.K252587HD 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.K252179GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive OnlyShenzhen RF Tech Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.