Medical Device Manufacturer · US , Eden Prairie , MN

Acist Medical Systems, Inc. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2001

Recent clearances: VueJect® Ultrasound Enhancing Agent Delivery System, VeraPro S100 Multi-Use Syringe (018808), ACIST Pro Diagnostic System (019304)

17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Acist Medical Systems, Inc. General Hospital ✕

5 devices

1-5 of 5

Cleared Aug 03, 2026

VueJect® Ultrasound Enhancing Agent Delivery System

General Hospital · 41d

Cleared May 13, 2026

VeraPro S100 Multi-Use Syringe (018808)

General Hospital · 266d

Cleared May 13, 2026

ACIST Pro Diagnostic System (019304)

General Hospital · 264d

Cleared Dec 17, 2020

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System

General Hospital · 77d

Cleared Jul 18, 2019

ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit,...

General Hospital · 87d