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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Contrast Medium, Automatic
510(k) Number K262115
Device Name VueJect® Ultrasound Enhancing Agent Delivery System
Applicant
ACIST Medical Systems, Inc.
7905 Fuller Rd.
Eden Prairie,  MN  55344
Applicant Contact Linda Busklein
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1650
Classification Product Code
IZQ  
Date Received06/23/2026
Decision Date 08/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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