VueJect® Ultrasound Enhancing Agent Delivery System
FDA 510(k) K262115 · ACIST Medical Systems, Inc.
510(k) numberK262115
Submission
- Device name
- VueJect® Ultrasound Enhancing Agent Delivery System
- Applicant
- ACIST Medical Systems, Inc.
Eden Prairie, MN, US - Received
- June 23, 2026
- Decision date
- August 3, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- IZQ – Injector, Contrast Medium, Automatic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
Other 510(k)s with product code IZQ
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| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | Ulrich GmbH & Co. KG | 11/18/2025SE |
| K251295 | ulrichINJECT CT Motion (XD 8000)IZQ · Traditional | Ulrich GmbH & Co. KG | 11/07/2025SE |
| K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…IZQ · Special | Imaxeon Pty, Ltd. | 09/24/2025SE |
| K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…IZQ · Traditional | Imaxeon Pty, Ltd. | 11/05/2024SE |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | Ulrich GmbH & Co. KG | 08/26/2024SE |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | Ulrich GmbH & Co. KG | 04/19/2024SE |
| K210541 | ulrichINJECT CT motionIZQ · Traditional | Ulrich GmbH & Co. KG | 08/06/2021SE |
| K192872 | ulrichINJECT CT MotionIZQ · Traditional | Ulrich GmbH & Co. KG | 07/02/2020SE |
| K171392 | ulrichINJECT CT motionIZQ · Traditional | Ulrich GmbH & Co. KG | 11/09/2017SE |
| K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP…IZQ · Traditional | Bracco Injeneering | 01/22/2016SE |
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| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…DXT · Traditional | 05/13/2026SE |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_DXO · Traditional | 07/17/2024SE |
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemDXT · Special | 12/17/2020SE |
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterOBJ · Special | 03/20/2020SE |
| K190473 | ACIST RXi System and Navvus II CatheterOBI · Traditional | 09/13/2019SE |
| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000…DXT · Traditional | 07/18/2019SE |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOBJ · Traditional | 06/27/2019SE |
| K171646 | ACISTCVi® Contrast Delivery SystemDXT · Traditional | 02/16/2018SE |
| K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOBJ · Special | 10/23/2017SE |
Questions and answers
When was VueJect® Ultrasound Enhancing Agent Delivery System cleared by the FDA?
VueJect® Ultrasound Enhancing Agent Delivery System (K262115) received a 510(k) decision of Substantially Equivalent on August 3, 2026, 41 days after the submission was received.
What is the product code of K262115?
The FDA product code is IZQ – Injector, Contrast Medium, Automatic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.