FDA 510(k)

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support

N.º K: K191539 · 2020-01-31

Fecha de decisión2020-01-31

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Biomedical GmbH. It received FDA 510(k) clearance on 2020-01-31 under 510(k) number K191539. 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 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support?

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support is a medical device that received FDA 510(k) clearance on 2020-01-31. The listed applicant is Rapid Biomedical GmbH. The 510(k) number is K191539.

When did 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support receive FDA 510(k) clearance?

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support received FDA 510(k) clearance on 2020-01-31, under 510(k) number K191539.

Who is the listed applicant for 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support?

The FDA 510(k) record lists Rapid Biomedical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support?

The FDA product code for 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support is MOS.

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Otros registros que enlistan a Rapid Biomedical GmbH como solicitante

K21348031P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil K1819481.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil K163661P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil

Dispositivos relacionados (Código: MOS)

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Bobina de MamaNeocoil, LLC K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

Fuente oficial

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