510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K262115Substantially Equivalent

VueJect® Ultrasound Enhancing Agent Delivery System

Acist Medical Systems, Inc., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K262115 is the FDA 510(k) clearance record for VueJect® Ultrasound Enhancing Agent Delivery System, a class II device, cleared for ACIST Medical Systems, Inc. on under FDA product code IZQ (Injector, Contrast Medium, Automatic). FDA records list 24 510(k) clearances for ACIST Medical Systems, Inc., from to . As of , FDA records show no recalls naming K262115.

Clearance record

Decision date
Received
(41 days to decision)
Product code
IZQ Injector, Contrast Medium, Automatic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
ACIST Medical Systems, Inc. 7905 Fuller Rd., Eden Prairie MN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IZQ

Trailing 12 months
3 clearances under product code IZQ in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IZQ, trailing twelve months
MonthClearances
November 20252
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260