FDA 510(k)

VueJect® Ultrasound Enhancing Agent Delivery System

N.º K: K262115 · 2026-08-03

Fecha de decisión2026-08-03

Código de productoIZQ

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

VueJect® Ultrasound Enhancing Agent Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is ACIST Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-08-03 under 510(k) number K262115. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the VueJect® Ultrasound Enhancing Agent Delivery System?

VueJect® Ultrasound Enhancing Agent Delivery System is a medical device that received FDA 510(k) clearance on 2026-08-03. The listed applicant is ACIST Medical Systems, Inc.. The 510(k) number is K262115.

When did VueJect® Ultrasound Enhancing Agent Delivery System receive FDA 510(k) clearance?

VueJect® Ultrasound Enhancing Agent Delivery System received FDA 510(k) clearance on 2026-08-03, under 510(k) number K262115.

¿Quién es el solicitante registrado para el Sistema de Entrega de Agente de Mejora de Ultrasonido VueJect®?

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

What is the FDA product code for VueJect® Ultrasound Enhancing Agent Delivery System?

The FDA product code for VueJect® Ultrasound Enhancing Agent Delivery System is IZQ.

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 ACIST Medical Systems, Inc. como solicitante

K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)K252653Sistema de Diagnóstico ACIST Pro (019304); Unidad de Procesamiento Montada en Cama; Módulo AngioTouch; Carro ACIST Pro; Cable de Transductor Único; Cable de Transductor Triple K233904Sistema RXi ACIST (016616); Catéter Navvus II ACIST (016675_)K203004Sistema de Entrega de Contraste ACIST CVi1, Sistema de Entrega de Contraste ACIST CVi K193183Sistema ACIST HDi, Catéter de Ultrasonido Intravascular ACIST Kodama K190473Sistema RXi ACIST y Catéter Navvus II

Ver todos los 12 dispositivos →

Dispositivos relacionados (Código: IZQ)

K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG K252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG

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.