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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
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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