FDA 510(k)

Aixplorer MACH 30, Aixplorer MACH 20 Sistemas de Diagnóstico por Ultrassonografia

Número K: K191007 · 2019-10-25

Data da decisão2019-10-25

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems is the device name listed in this FDA 510(k) record. The listed applicant is Supersonic Imagine. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K191007. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems?

Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Supersonic Imagine. The 510(k) number is K191007.

When did Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems receive FDA 510(k) clearance?

Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems received FDA 510(k) clearance on 2019-10-25, under 510(k) number K191007.

Who is the listed applicant for Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems?

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

What is the FDA product code for Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems?

The FDA product code for Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems is IYN.

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

Outros registros que listam Supersonic Imagine como candidato(a)

K242223SuperSonic HepaVu K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Sistemas de Diagnóstico por Ultrassonografia K180572Sistemas de Diagnóstico por Ultrassonografia AIXPLORER MACH Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 K173021Aixplorer & Aixplorer Ultimate Sistemas de Diagnóstico por Ultrassonografia

Ver todos os 9 dispositivos →

Dispositivos Relacionados (Código: IYN)

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.