FDA 510(k)

Vscan Extend

N.º K: K161588 · 2016-08-31

SolicitanteGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Fecha de decisión2016-08-31

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Vscan Extend is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2016-08-31 under 510(k) number K161588. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Vscan Extend?

Vscan Extend is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K161588.

When did Vscan Extend receive FDA 510(k) clearance?

Vscan Extend received FDA 510(k) clearance on 2016-08-31, under 510(k) number K161588.

Who is the listed applicant for Vscan Extend?

The FDA 510(k) record lists GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vscan Extend?

The FDA product code for Vscan Extend is IYN.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC como solicitante

K261668Venue Go K252718Lunar Astra K254161Automated Aortic Stenosis Software (AutoAS)K221148Vivid iq K203677ViewPoint 6 K200158LOGIQ E10

Ver todos los 15 dispositivos →

Dispositivos relacionados (Código: IYN)

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.