FDA Product Code IZQ: Injector, Contrast Medium, Automatic
Under FDA product code IZQ, automatic contrast medium injectors are cleared for the power injection of iodinated contrast agents during CT, angiography, and MRI examinations.
These programmable devices deliver precise volumes of contrast at controlled flow rates and pressures, ensuring consistent vascular enhancement and image quality. They are used in CT angiography, coronary angiography, and enhanced MRI protocols.
IZQ devices are Class II medical devices, regulated under 21 CFR 870.1650 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Ulrich GmbH & Co. KG, E-Z-Em, Inc. and Imaxeon Pty, Ltd..
23
Total
23
Cleared
139d
Avg days
1976
Since
Growing category -
5 submissions in the last 2 years
vs 2 in the prior period
Review times improving: avg
103d
recently vs 150d historically
FDA 510(k) Cleared Injector, Contrast Medium, Automatic Devices (Product Code IZQ)
23 devices
Cleared
Aug 03, 2026
VueJect® Ultrasound Enhancing Agent Delivery System
Acist Medical Systems, Inc.
General Hospital
41d
Cleared
Nov 18, 2025
ulricheasyINJECT Max 2M (XD 10140)
Ulrich GmbH & Co. KG
General Hospital
119d
Cleared
Nov 07, 2025
ulrichINJECT CT Motion (XD 8000)
Ulrich GmbH & Co. KG
General Hospital
196d
Cleared
Sep 24, 2025
MEDRAD Centargo CT Injection System
Imaxeon Pty, Ltd.
General Hospital
29d
Cleared
Nov 05, 2024
MEDRAD Centargo CT Injection System
Imaxeon Pty, Ltd.
General Hospital
131d
Cleared
Aug 26, 2024
ulricheasyINJECT Max 2M (XD 10140)
Ulrich GmbH & Co. KG
General Hospital
60d
Cleared
Apr 19, 2024
ulricheasyINJECT Max 2M (XD 10140)
Ulrich GmbH & Co. KG
General Hospital
149d
Cleared
Aug 06, 2021
ulrichINJECT CT motion
Ulrich GmbH & Co. KG
General Hospital
163d
Cleared
Jul 02, 2020
ulrichINJECT CT Motion
Ulrich GmbH & Co. KG
General Hospital
268d
Cleared
Nov 09, 2017
ulrichINJECT CT motion
Ulrich GmbH & Co. KG
Cardiovascular
182d
Cleared
Jan 22, 2016
CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
Bracco Injeneering
Cardiovascular
277d
Cleared
Jan 14, 2016
OptiOne Single-Head Contrast Delivery System with Pedestal
Liebel-Flarsheim Company, LLC
Cardiovascular
147d
Cleared
Apr 13, 2007
EMPOWERMR INJECTOR SYSTEM, MODEL 9730
E-Z-Em, Inc.
Cardiovascular
234d
Cleared
Mar 27, 2007
MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY
Medrad, Inc.
Cardiovascular
168d
Cleared
Jun 19, 2003
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
E-Z-Em, Inc.
Radiology
30d
Cleared
Feb 19, 1999
PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM
Nycomed Amersham Imaging
Cardiovascular
151d
Cleared
Feb 11, 1999
ACIST INJECTOR SYSTEM, MODEL CL100 H
Acist Medical Systems
Cardiovascular
90d
Cleared
Oct 08, 1976
MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular
24d
Cleared
Oct 08, 1976
MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular
24d
About Product Code IZQ - Regulatory Context
510(k) Submission Activity
23 total 510(k) submissions under product code IZQ since 1976, with 23 receiving FDA clearance (average review time: 139 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - IZQ Product Code
Recent submissions under IZQ have taken an average of 103 days to reach a decision - down from 150 days historically, suggesting improved FDA processing for this classification.
IZQ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →