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FDA 510(k)

VueJect® Ultrasound Enhancing Agent Delivery System

K-Number: K262115 · 2026-08-03

ApplicantACIST Medical Systems, Inc.
Decision Date2026-08-03
Product CodeIZQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Who is the listed applicant for VueJect® Ultrasound Enhancing Agent Delivery System?

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.

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Other records listing ACIST Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableK252638VeraPro 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)K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemK193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterK190473ACIST RXi System and Navvus II Catheter

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Related Devices (Code: IZQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KGK251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KGK252689MEDRAD 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. KGK233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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