510(k) K262115 · IZQ Injector, Contrast Medium, Automatic
VueJect® Ultrasound Enhancing Agent Delivery System
| Applicant | ACIST Medical Systems, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Aug 3, 2026 |
| Received | Jun 23, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262115
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.