FDA 510(k)

OARtrac System with Patient Specific Reusable Universal PSD Sensors

Número K: K162954 · 2017-06-01

Data da decisão2017-06-01

Código do produtoNZT

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

OARtrac System with Patient Specific Reusable Universal PSD Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Radiadyne, LLC. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K162954. The device is classified under product code NZT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OARtrac System with Patient Specific Reusable Universal PSD Sensors?

OARtrac System with Patient Specific Reusable Universal PSD Sensors is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Radiadyne, LLC. The 510(k) number is K162954.

When did OARtrac System with Patient Specific Reusable Universal PSD Sensors receive FDA 510(k) clearance?

OARtrac System with Patient Specific Reusable Universal PSD Sensors received FDA 510(k) clearance on 2017-06-01, under 510(k) number K162954.

Who is the listed applicant for OARtrac System with Patient Specific Reusable Universal PSD Sensors?

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

What is the FDA product code for OARtrac System with Patient Specific Reusable Universal PSD Sensors?

The FDA product code for OARtrac System with Patient Specific Reusable Universal PSD Sensors is NZT.

Ensaios clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: NZT)

K250083PRO-DOSE SystemNu-Rise, SA K182395OARtrac SystemRadialdyne, LLC

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.