FDA 510(k)

1.5T HD T/R Arranjo de Joelho (10-F34127)

Número K: K231085 · 2023-08-18

Data da decisão2023-08-18

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

1.5T HD T/R Knee Array (10-F34127) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen RF Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K231085. 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 1.5T HD T/R Knee Array (10-F34127)?

1.5T HD T/R Knee Array (10-F34127) is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Shenzhen RF Tech Co., Ltd.. The 510(k) number is K231085.

When did 1.5T HD T/R Knee Array (10-F34127) receive FDA 510(k) clearance?

1.5T HD T/R Knee Array (10-F34127) received FDA 510(k) clearance on 2023-08-18, under 510(k) number K231085.

Who is the listed applicant for 1.5T HD T/R Knee Array (10-F34127)?

The FDA 510(k) record lists Shenzhen RF Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1.5T HD T/R Knee Array (10-F34127)?

The FDA product code for 1.5T HD T/R Knee Array (10-F34127) is MOS.

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K252587HD 8Ch Wrist Array 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 Only K252179GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only K2232031.5T 24E Arranjo Posterior K2232258ch Fio de R/T de Joelho K2232398ch Fio de Pulso

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Fonte oficial

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