FDA 510(k)

3.0T 16ch AIR AA

N.º K: K223378 · 2023-01-03

SolicitanteGe Healthcare Coils (Usa Instruments, Inc.)

Fecha de decisión2023-01-03

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

3.0T 16ch AIR AA 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 2023-01-03 under 510(k) number K223378. 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 3.0T 16ch AIR AA?

3.0T 16ch AIR AA is a medical device that received FDA 510(k) clearance on 2023-01-03. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K223378.

When did 3.0T 16ch AIR AA receive FDA 510(k) clearance?

3.0T 16ch AIR AA received FDA 510(k) clearance on 2023-01-03, under 510(k) number K223378.

Who is the listed applicant for 3.0T 16ch AIR AA?

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 3.0T 16ch AIR AA?

The FDA product code for 3.0T 16ch AIR AA 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 K1825043.0T Air MP M, 3.0T Air MP L K180666Coil de Cabeza 48CH K172695AIR Anterior Array, AIR Posterior Array K163205Coil de Cabeza 48CH

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Fuente oficial

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