K262115
- 510(k) number
- K262115
- Device name
- VueJect® Ultrasound Enhancing Agent Delivery System
- Applicant
- ACIST Medical Systems, Inc. MN · US
- Product code
- IZQ — Injector, Contrast Medium, Automatic
- Decision date
- 2026-08-03
- Date received
- 2026-06-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K262115.pdf
Official FDA record: K262115
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.