FDA 510(k)

16ch Bobina T/R Joelho

Número K: K162029 · 2016-10-18

Data da decisão2016-10-18

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

16ch T/R Knee Coil is the device name listed in this FDA 510(k) record. The listed applicant is Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K162029. 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 16ch T/R Knee Coil?

16ch T/R Knee Coil is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Quality Electrodynamics, LLC. The 510(k) number is K162029.

When did 16ch T/R Knee Coil receive FDA 510(k) clearance?

16ch T/R Knee Coil received FDA 510(k) clearance on 2016-10-18, under 510(k) number K162029.

Who is the listed applicant for 16ch T/R Knee Coil?

The FDA 510(k) record lists Quality Electrodynamics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 16ch T/R Knee Coil?

The FDA product code for 16ch T/R Knee Coil is MOS.

Outros registros que listam Quality Electrodynamics, LLC 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.

K242006SureWave Elastography (Q7000225)K223429Contour Knee K200477Flex Body Speeder K193140Flex Body SPEEDER K183111Contour 24 K18169716ch SPEEDER de Pé/ Tornozelo

Ver todos os 14 dispositivos →

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 PeitoNeocoil, 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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.