Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

TheraVision Ultrasound Ablation System and ACOUSTx Applicators

Número K: K150019 · 2016-01-13

RequerenteAcoustic Medsystems, Inc.
Data da decisão2016-01-13
Código do produtoNTB
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

TheraVision Ultrasound Ablation System and ACOUSTx Applicators is the device name listed in this FDA 510(k) record. The listed applicant is Acoustic Medsystems, Inc.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K150019. The device is classified under product code NTB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TheraVision Ultrasound Ablation System and ACOUSTx Applicators?

TheraVision Ultrasound Ablation System and ACOUSTx Applicators is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Acoustic Medsystems, Inc.. The 510(k) number is K150019.

When did TheraVision Ultrasound Ablation System and ACOUSTx Applicators receive FDA 510(k) clearance?

TheraVision Ultrasound Ablation System and ACOUSTx Applicators received FDA 510(k) clearance on 2016-01-13, under 510(k) number K150019.

Who is the listed applicant for TheraVision Ultrasound Ablation System and ACOUSTx Applicators?

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

What is the FDA product code for TheraVision Ultrasound Ablation System and ACOUSTx Applicators?

The FDA product code for TheraVision Ultrasound Ablation System and ACOUSTx Applicators is NTB.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑