FDA 510(k)

Sistema de Ultra-som Volumétrico Inteligente Avançado, Modelo AiVUS 1000

Número K: K190314 · 2019-10-09

Data da decisão2019-10-09

Código do produtoIYO

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Mednovel Technology, Ltd.. It received FDA 510(k) clearance on 2019-10-09 under 510(k) number K190314. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000?

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 is a medical device that received FDA 510(k) clearance on 2019-10-09. The listed applicant is Mednovel Technology, Ltd.. The 510(k) number is K190314.

When did Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 receive FDA 510(k) clearance?

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 received FDA 510(k) clearance on 2019-10-09, under 510(k) number K190314.

Who is the listed applicant for Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000?

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

What is the FDA product code for Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000?

The FDA product code for Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 is IYO.

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: IYO)

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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.