Injector, Contrast Medium, Automatic
FDA product code IZQ · Class II (moderate risk) · 21 CFR 870.1650 · Cardiovascular
23510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Ulrich GmbH & Co. KG 7
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Acist Medical Systems, Inc. 2
- E-Z-Em, Inc. 2
- Imaxeon Pty, Ltd. 2
- Kenex , Ltd. 1
- Nycomed Amersham Imaging 1
- Swiss Medical Care S.A. 1
- Medrad, Inc. 1
- Mallinckrodt Inc., Liebel-Flarsheim Business 1
- Nemoto Kyorindo Co., Ltd. 1
- Liebel-Flarsheim Company LLC 1
- Bracco Injeneering 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery SystemIZQ · Traditional | ACIST Medical Systems, Inc. | 08/03/2026SE |
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | Ulrich GmbH & Co. KG | 11/18/2025SE |
| K251295 | ulrichINJECT CT Motion (XD 8000)IZQ · Traditional | Ulrich GmbH & Co. KG | 11/07/2025SE |
| K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…IZQ · Special | Imaxeon Pty, Ltd. | 09/24/2025SE |
| K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…IZQ · Traditional | Imaxeon Pty, Ltd. | 11/05/2024SE |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | Ulrich GmbH & Co. KG | 08/26/2024SE |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…IZQ · Traditional | Ulrich GmbH & Co. KG | 04/19/2024SE |
| K210541 | ulrichINJECT CT motionIZQ · Traditional | Ulrich GmbH & Co. KG | 08/06/2021SE |
| K192872 | ulrichINJECT CT MotionIZQ · Traditional | Ulrich GmbH & Co. KG | 07/02/2020SE |
| K171392 | ulrichINJECT CT motionIZQ · Traditional | Ulrich GmbH & Co. KG | 11/09/2017SE |
| K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP…IZQ · Traditional | Bracco Injeneering | 01/22/2016SE |
| K152361 | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling…IZQ · Traditional | Liebel-Flarsheim Company, LLC | 01/14/2016SE |
| K091734 | Sonic Shot GXIZQ · Traditional | Nemoto Kyorindo Co., Ltd. | 05/21/2010SE |
| K063503 | Optivantage DH Injector System with Enhanced CommunicationIZQ · Special | Mallinckrodt Inc., Liebel-Flarsheim Business | 04/27/2007SE |
| K062449 | Empowermr Injector System, Model 9730IZQ · Abbreviated | E-Z-Em, Inc. | 04/13/2007SE |
| K063090 | Medrad Stellant CT Injector System with XDS AccessoryIZQ · Traditional | Medrad, Inc. | 03/27/2007SE |
| K062265 | CT Expres III Contrast Media Delivery SystemIZQ · Traditional | Swiss Medical Care S.A. | 12/26/2006SE |
| K031571 | Empowercta Injector System, Models 9930 & 9910 & 9825IZQ · Special | E-Z-Em, Inc. | 06/19/2003SE |
| K983314 | Premica CT Contrast Media Delivery SystemIZQ · Traditional | Nycomed Amersham Imaging | 02/19/1999SE |
| K984058 | Acist Injector System, Model CL100 HIZQ · Traditional | Acist Medical Systems | 02/11/1999SE |
| K951005 | Kenex Injector Head Support (AS Exhibit 2)IZQ · Traditional | Kenex , Ltd. | 05/04/1995SE |
| K760643 | Myelography Tray W/Cuatico Myelograp NIZQ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/08/1976SE |
| K760641 | Myelography Tray W/Chynn Myelography NIZQ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/08/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0830-2012 | Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL…Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product… | Mallinckrodt Inc | 10/11/2011Terminated |
| Z-2859-2011 | Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103)…Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product… | Mallinckrodt Inc | 05/20/2011Terminated |
| Z-1694-2008 | The OptiVantage DH Injection System is a contrast delivery system and is designed to…Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This… | Mallinckrodt Inc | 04/07/2008Terminated |