FDA 510(k)

3.0T AIR 32CH HNA

N.º K: K253738 · 2026-01-23

SolicitanteGe Healthcare Coils (Usa Instruments, Inc.)

Fecha de decisión2026-01-23

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

3.0T AIR 32CH HNA 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 2026-01-23 under 510(k) number K253738. 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 AIR 32CH HNA?

3.0T AIR 32CH HNA is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K253738.

When did 3.0T AIR 32CH HNA receive FDA 510(k) clearance?

3.0T AIR 32CH HNA received FDA 510(k) clearance on 2026-01-23, under 510(k) number K253738.

Who is the listed applicant for 3.0T AIR 32CH HNA?

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 AIR 32CH HNA?

The FDA product code for 3.0T AIR 32CH HNA 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.

K2233783.0T 16ch AIR AA 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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