VueJect® Ultrasound Enhancing Agent Delivery System— 510(k) K262115
Substantially EquivalentACIST Medical Systems, Inc.
FDA 510(k) clearance K262115 for VueJect® Ultrasound Enhancing Agent Delivery System, Substantially Equivalent on 2026-08-03. Applicant: ACIST Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- ACIST Medical Systems, Inc.
- Product code
- Code IZQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Recent devices under product code IZQ
view all- K252281 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- K251295 — ulrichINJECT CT Motion (XD 8000)
- K252689 — MEDRAD Centargo CT Injection System +4 more
- K241849 — MEDRAD Centargo CT Injection System +4 more
- K241850 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
More clearances from ACIST Medical Systems, Inc.
view all- K252638 — VeraPro S100 Multi-Use Syringe (018808) +4 more
- K252653 — ACIST Pro Diagnostic System (019304) +5 more
- K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
- K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
- K193183 — ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
Adverse events under product code IZQ
product code IZQ- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.