# K262115: VueJect® Ultrasound Enhancing Agent Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: ACIST Medical Systems, Inc.
- Decided: Aug 3, 2026 after 41 days
- Product code: IZQ (Injector, Contrast Medium, Automatic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K011160 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071378: Modification to Empower CT/Cta Injector System, Models 9800/9900 Product Series, E-Z-Em, Inc. (2007) Summary page 5.

## Indications for use
The VueJect Ultrasound Enhancing Agent Delivery System is intended for controlled intravenous delivery of ultrasound contrast agents in patients undergoing diagnostic ultrasound procedures. For a list of compatible contrast agents, consult the User Guide for the VueJect Ultrasound Enhancing Agent Delivery System.

Source page: https://510kreport.com/device/K262115
Methodology: https://510kreport.com/methodology