FDA cleared the VueJect® Ultrasound Enhancing Agent Delivery System from ACIST Medical Systems, Inc. on Aug 3, 2026 under K262115, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code IZQ, Injector, Contrast Medium, Automatic, regulated at 21 CFR 870.1650 as a Class 2 device. The review panel was Cardiovascular.
FDA logged the submission as received on Jun 23, 2026. The decision came 41 days later, inside the 90 FDA-day goal for a 510(k).
ACIST Medical Systems, Inc. has 2 other decisions in the tracker over the last 12 months: K252638 (VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)), K252653 (ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable).