510(k) · Cleared
ClearedVueJect® Ultrasound Enhancing Agent Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACIST Medical Systems, Inc. · IZQ Injector, Contrast Medium, Automatic
Cleared on Aug 3, 2026 as substantially equivalent to K071378 (E-Z-Em, Inc., 2007) after a 41-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Aug 3, 2026
- Review
- 41 days
- Class
- Class II
- Product code
- IZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011160 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK011160 E-Z EM Percupump 2001 CT InjectorE-Z-Em, Inc. · 2001 · Recalled
- 3 generations backK031571 Empowercta Injector System, Models 9930 & 9910 & 9825E-Z-Em, Inc. · 2003 · Recalled
- 2 generations backK063029 Empower CT/Cta Injector System, Model 9800/9900E-Z-Em, Inc. · 2006
- 1 generation backK071378 Modification to Empower CT/Cta Injector System, Models 9800/9900…E-Z-Em, Inc. · 2007
- This deviceK262115 VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011160 | E-Z EM Percupump 2001 CT Injector | E-Z-Em, Inc. | 2001 | 3 |
| −3 | K031571 | Empowercta Injector System, Models 9930 & 9910 & 9825 | E-Z-Em, Inc. | 2003 | 3 |
| −2 | K063029 | Empower CT/Cta Injector System, Model 9800/9900 | E-Z-Em, Inc. | 2006 | — |
| −1 | K071378 | Modification to Empower CT/Cta Injector System, Models 9800/9900 Product Series | E-Z-Em, Inc. | 2007 | — |
| 0 (this device) | K262115 | VueJect® Ultrasound Enhancing Agent Delivery System | ACIST Medical Systems, Inc. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZQ device
- #1 K241850 ulricheasyINJECT Max 2M (XD 10140)…score 12.7 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071378 | Modification to Empower CT/Cta Injector System, Models 9800/9900 Product SeriesSummary page 5…Medium Angiographic syringe and Injector accessories 510(k) Number K071378 K241109 Classification Name Computed tomography x-ray Angiogra… | 2007 |
| † | K241109 | Single-use Sterile High-pressure Angiographic Syringes and Accessories | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All IZQ devicesIZQ Injector, Contrast Medium, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · IZQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZQ
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZQ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZQ
21in 2025
MAUDE reports naming product code IZQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 168 | 0 | 14 |
| 2008 | 0 | — | 1 | 72 |
| 2009 | 0 | — | 0 | 48 |
| 2010 | 1 | — | 0 | 42 |
| 2011 | 0 | — | 2 | 41 |
| 2012 | 0 | — | 0 | 23 |
| 2013 | 0 | — | 0 | 23 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 1 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 3 | 131 | 0 | 23 |
| 2025 | 3 | 119 | 0 | 21 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262115: VueJect® Ultrasound Enhancing Agent Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262115
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026