FDA 510(k)

3.0T AIR 32CH HNA

Número K: K253738 · 2026-01-23

RequerenteGe Healthcare Coils (Usa Instruments, Inc.)

Data da decisão2026-01-23

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

Outros registros que listam Ge Healthcare Coils (Usa Instruments, Inc.) como candidato(a)

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Fonte oficial

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