FDA 510(k)

48CH Head Coil

Número K: K180666 · 2018-04-12

RequerenteGe Healthcare Coils (Usa Instruments, Inc.)

Data da decisão2018-04-12

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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 K2233783.0T 16ch AIR AA K1825043.0T Air MP M, 3.0T Air MP L K172695AIR Anterior Array, AIR Posterior Array K16320548CH Head Coil

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