Clearance Summary
VueJect® Ultrasound Enhancing Agent Delivery System received FDA 510(k) clearance under submission number K262115, sponsored by ACIST Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-08-03.
- Submission: K262115
- Applicant / Sponsor: ACIST Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 2026-08-03
Classification & Regulation
This clearance is catalogued under FDA product code IZQ and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.