Panels › Cardiovascular › Product code IZQ · Class 2
Injector, Contrast Medium, Automatic
Regulation 870.1650
3510(k)s in 12 months (23 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in IZQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ulrich GmbH & Co. KG | 7 | 0 |
| Mallinckrodt Inc | 0 | 3 |
| ACIST Medical Systems, Inc. | 2 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 0 |
| E-Z-Em, Inc. | 2 | 0 |
| Imaxeon Pty, Ltd. | 2 | 0 |
| Bracco Injeneering | 1 | 0 |
| Kenex , Ltd. | 1 | 0 |
| Liebel-Flarsheim Company, LLC | 1 | 0 |
| Mallinckrodt Inc., Liebel-Flarsheim Business | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 3, 2026 | K262115 | VueJect® Ultrasound Enhancing Agent Delivery System ACIST Medical Systems, Inc. | IZQ |
| Nov 18, 2025 | K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) Ulrich GmbH & Co. KG, DE | IZQ |
| Nov 7, 2025 | K251295 | ulrichINJECT CT Motion (XD 8000) Ulrich GmbH & Co. KG, DE | IZQ |
| Sep 24, 2025 | K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Imaxeon Pty, Ltd., AU | IZQ |
| Nov 5, 2024 | K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Imaxeon Pty, Ltd., AU | IZQ |
| Aug 26, 2024 | K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) Ulrich GmbH & Co. KG, DE | IZQ |
| Apr 19, 2024 | K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) Ulrich GmbH & Co. KG, DE | IZQ |
| Aug 6, 2021 | K210541 | ulrichINJECT CT motion Ulrich GmbH & Co. KG, DE | IZQ |
| Jul 2, 2020 | K192872 | ulrichINJECT CT Motion Ulrich GmbH & Co. KG, DE | IZQ |
| Nov 9, 2017 | K171392 | ulrichINJECT CT motion Ulrich GmbH & Co. KG, DE | IZQ |
| Jan 22, 2016 | K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set Bracco Injeneering, CH | IZQ |
| Jan 14, 2016 | K152361 | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System Liebel-Flarsheim Company, LLC | IZQ |
| May 21, 2010 | K091734 | SONIC SHOT GX Nemoto Kyorindo Co., Ltd., JP | IZQ |
| Apr 27, 2007 | K063503 | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION Mallinckrodt Inc., Liebel-Flarsheim Business | IZQ |
| Apr 13, 2007 | K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 E-Z-Em, Inc. | IZQ |
| Mar 27, 2007 | K063090 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY Medrad, Inc. | IZQ |
| Dec 26, 2006 | K062265 | CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM Swiss Medical Care S.A. | IZQ |
| Jun 19, 2003 | K031571 | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 E-Z-Em, Inc. | IZQ |
| Feb 19, 1999 | K983314 | PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM Nycomed Amersham Imaging | IZQ |
| Feb 11, 1999 | K984058 | ACIST INJECTOR SYSTEM, MODEL CL100 H Acist Medical Systems | IZQ |
| May 4, 1995 | K951005 | KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) Kenex , Ltd., GB | IZQ |
| Oct 8, 1976 | K760643 | MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N Bd Becton Dickinson Vacutainer Systems Preanalytic | IZQ |
| Oct 8, 1976 | K760641 | MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N Bd Becton Dickinson Vacutainer Systems Preanalytic | IZQ |
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