FDA 510(k)

X9 Ultrasound System

Número K: K251673 · 2025-10-17

Data da decisão2025-10-17

Código do produtoSGH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

X9 Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is X9, Inc.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K251673. The device is classified under product code SGH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the X9 Ultrasound System?

X9 Ultrasound System is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is X9, Inc.. The 510(k) number is K251673.

When did X9 Ultrasound System receive FDA 510(k) clearance?

X9 Ultrasound System received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251673.

Who is the listed applicant for X9 Ultrasound System?

The FDA 510(k) record lists X9, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X9 Ultrasound System?

The FDA product code for X9 Ultrasound System is SGH.

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

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.