IZQ · Injector, Contrast Medium, Automatic
Cardiovascular · 21 CFR 870.1650 · Class 2
Overview
| Product Code | IZQ |
|---|---|
| Device Name | Injector, Contrast Medium, Automatic |
| Regulation | 21 CFR 870.1650 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Special Controls
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (20 of 22)
Showing 20 most recent of 22 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | Nov 18, 2025 | SESE |
| K251295 | ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG | Nov 7, 2025 | SESE |
| K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty, Ltd. | Sep 24, 2025 | SESE |
| K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty, Ltd. | Nov 5, 2024 | SESE |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | Aug 26, 2024 | SESE |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | Apr 19, 2024 | SESE |
| K210541 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | Aug 6, 2021 | SESE |
| K192872 | ulrichINJECT CT Motion | Ulrich GmbH & Co. KG | Jul 2, 2020 | SESE |
| K171392 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | Nov 9, 2017 | SESE |
| K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set | Bracco Injeneering | Jan 22, 2016 | SESE |
| K152361 | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System | Liebel-Flarsheim Company, LLC | Jan 14, 2016 | SESE |
| K091734 | SONIC SHOT GX | Nemoto Kyorindo Co., Ltd. | May 21, 2010 | SESE |
| K063503 | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION | Mallinckrodt Inc., Liebel-Flarsheim Business | Apr 27, 2007 | SESE |
| K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | E-Z-Em, Inc. | Apr 13, 2007 | SESE |
| K063090 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY | Medrad, Inc. | Mar 27, 2007 | SESE |
| K062265 | CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM | Swiss Medical Care S.A. | Dec 26, 2006 | SESE |
| K031571 | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | E-Z-Em, Inc. | Jun 19, 2003 | SESE |
| K983314 | PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM | Nycomed Amersham Imaging | Feb 19, 1999 | SESE |
| K984058 | ACIST INJECTOR SYSTEM, MODEL CL100 H | Acist Medical Systems | Feb 11, 1999 | SESE |
| K951005 | KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) | Kenex , Ltd. | May 4, 1995 | SESE |
Top Applicants
- Ulrich GmbH & Co. KG — 7 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
- E-Z-Em, Inc. — 2 clearances
- Imaxeon Pty, Ltd. — 2 clearances
- Acist Medical Systems — 1 clearance
