FDA 510(k)

3.0T 16ch AIR AA

Número K: K223378 · 2023-01-03

RequerenteGe Healthcare Coils (Usa Instruments, Inc.)

Data da decisão2023-01-03

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K2537383.0T AIR 32CH HNA K1825043.0T Air MP M, 3.0T Air MP L K18066648CH Head Coil K172695AIR Anterior Array, AIR Posterior Array K16320548CH Head Coil

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Fonte oficial

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