Product code IZQ
- Device name
- Injector, Contrast Medium, Automatic
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1650
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | 2025-11-18 |
| K251295 | ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG | 2025-11-07 |
| 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. | 2025-09-24 |
| 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. | 2024-11-05 |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | 2024-08-26 |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | 2024-04-19 |
| K210541 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2021-08-06 |
| K192872 | ulrichINJECT CT Motion | Ulrich GmbH & Co. KG | 2020-07-02 |
| K171392 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2017-11-09 |
| K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set | Bracco Injeneering | 2016-01-22 |
| K152361 | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System | Liebel-Flarsheim Company, LLC | 2016-01-14 |
| K091734 | SONIC SHOT GX | Nemoto Kyorindo Co., Ltd. | 2010-05-21 |
| K063503 | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION | Mallinckrodt Inc., Liebel-Flarsheim Business | 2007-04-27 |
| K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | E-Z-Em, Inc. | 2007-04-13 |
| K063090 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY | Medrad, Inc. | 2007-03-27 |
| K062265 | CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM | Swiss Medical Care S.A. | 2006-12-26 |
| K031571 | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | E-Z-Em, Inc. | 2003-06-19 |
| K983314 | PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM | Nycomed Amersham Imaging | 1999-02-19 |
| K984058 | ACIST INJECTOR SYSTEM, MODEL CL100 H | Acist Medical Systems | 1999-02-11 |
| K951005 | KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) | Kenex , Ltd. | 1995-05-04 |
| K760641 | MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-10-08 |
| K760643 | MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-10-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09345390003523 | MEDRAD® Centargo Patient Line (350 cm) | IMAXEON PTY LTD | 2026-05-06 |
| 09345390003530 | MEDRAD® Centargo Patient Line | IMAXEON PTY LTD | 2025-12-10 |
| 09345390002717 | MEDRAD® Centargo Replacement Spike | IMAXEON PTY LTD | 2025-03-28 |
| 09345390003097 | MEDRAD® Centargo Day Set | IMAXEON PTY LTD | 2025-03-28 |
| 09345390002656 | MEDRAD® Centargo Patient Line | IMAXEON PTY LTD | 2025-03-28 |
| 17630039300910 | Injector Head | Bracco Injeneering SA | 2021-03-05 |
| 17630039300989 | Remote Control | Bracco Injeneering SA | 2020-05-04 |
| 17630039300958 | EmpowerSync® Power Supply | Bracco Injeneering SA | 2020-05-04 |
| 17630039300996 | Hydraulic Controller | Bracco Injeneering SA | 2019-05-24 |
| 17630039300842 | EmpowerSync® Power Supply | Bracco Injeneering SA | 2017-10-26 |
| 17630039300798 | Injector | Bracco Injeneering SA | 2017-10-26 |
| 17630039300866 | FastLoad™ MR Syringe Pack | Bracco Injeneering SA | 2017-10-20 |
| 17630039300484 | EmpowerSync® Power Supply | Bracco Injeneering SA | 2016-09-20 |
| 17630039300002 | CT Exprès™ - Bottle Spike Type A (30 mm) | Bracco Injeneering SA | 2016-09-20 |
| 17630039300019 | CT Exprès™ - Patient Set | Bracco Injeneering SA | 2016-09-20 |
| 17630039300026 | CT Exprès™ - Day Set III HP | Bracco Injeneering SA | 2016-09-20 |
| 17630039300101 | CT Exprès™ - Injector Unit | Bracco Injeneering SA | 2016-09-20 |
| 17630039300781 | Remote Control | Bracco Injeneering SA | 2016-09-20 |
| 17630039300767 | Remote Control (Onyx) | Bracco Injeneering SA | 2016-09-20 |
| 17630039300743 | Injector | Bracco Injeneering SA | 2016-09-20 |
| 17630039300118 | CT Exprès™ - Control Panel | Bracco Injeneering SA | 2016-09-20 |
| 17630039300477 | Remote Control | Bracco Injeneering SA | 2016-09-20 |
| 17630039300422 | EDA Module Kit | Bracco Injeneering SA | 2016-09-20 |
| 17630039300392 | Injector head | Bracco Injeneering SA | 2016-09-20 |
| 17630039300385 | Hydraulic Controller | Bracco Injeneering SA | 2016-09-20 |
| 17630039300378 | Remote Control | Bracco Injeneering SA | 2016-09-20 |
| 17630039300361 | Electro-Hydraulic Interconnect | Bracco Injeneering SA | 2016-09-20 |
| 17630039300347 | Extravasation Detection Patch with Access Slot | Bracco Injeneering SA | 2016-09-20 |
| 17630039300293 | FastLoad™ MR Syringe Pack | Bracco Injeneering SA | 2016-09-20 |
| 17630039300149 | Floor Stand | Bracco Injeneering SA | 2016-09-20 |