FDA 510(k)

Coil de Cabeza 48CH

N.º K: K180666 · 2018-04-12

SolicitanteGe Healthcare Coils (Usa Instruments, Inc.)

Fecha de decisión2018-04-12

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

48CH Head Coil is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). It received FDA 510(k) clearance on 2018-04-12 under 510(k) number K180666. 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 48CH Head Coil?

48CH Head Coil is a medical device that received FDA 510(k) clearance on 2018-04-12. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K180666.

When did 48CH Head Coil receive FDA 510(k) clearance?

48CH Head Coil received FDA 510(k) clearance on 2018-04-12, under 510(k) number K180666.

Who is the listed applicant for 48CH Head Coil?

The FDA 510(k) record lists Ge Healthcare Coils (Usa Instruments, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 48CH Head Coil?

The FDA product code for 48CH Head Coil is MOS.

Otros registros que enlistan a Ge Healthcare Coils (Usa Instruments, Inc.) como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K2537383.0T AIR 32CH HNA K2233783.0T 16ch AIR AA K1825043.0T Air MP M, 3.0T Air MP L K172695AIR Anterior Array, AIR Posterior Array K163205Coil de Cabeza 48CH

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.K2609470.55T 12Ch Bobina de MamaNeocoil, LLC 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.

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.