FDA 510(k)

TRILLIUM Oval Head Coil 32

N.º K: K162079 · 2016-09-16

SolicitanteHitachi Medical Systems America, Inc.

Fecha de decisión2016-09-16

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

TRILLIUM Oval Head Coil 32 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K162079. 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 TRILLIUM Oval Head Coil 32?

TRILLIUM Oval Head Coil 32 is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K162079.

When did TRILLIUM Oval Head Coil 32 receive FDA 510(k) clearance?

TRILLIUM Oval Head Coil 32 received FDA 510(k) clearance on 2016-09-16, under 510(k) number K162079.

Who is the listed applicant for TRILLIUM Oval Head Coil 32?

The FDA 510(k) record lists Hitachi Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRILLIUM Oval Head Coil 32?

The FDA product code for TRILLIUM Oval Head Coil 32 is MOS.

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Otros registros que enlistan a Hitachi Medical Systems America, Inc. como solicitante

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Dispositivos relacionados (Código: MOS)

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Fuente oficial

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