FDA Product Code
FDA Product Code IZQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1650
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery System | ACIST Medical Systems, Inc. | 2026-08-03 | Traditional | PDF ↗ |
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | 2025-11-18 | Traditional | PDF ↗ |
| K251295 | ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG | 2025-11-07 | Traditional | PDF ↗ |
| 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 | Special | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | 2024-08-26 | Traditional | PDF ↗ |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | Ulrich GmbH & Co. KG | 2024-04-19 | Traditional | PDF ↗ |
| K210541 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2021-08-06 | Traditional | PDF ↗ |
| K192872 | ulrichINJECT CT Motion | Ulrich GmbH & Co. KG | 2020-07-02 | Traditional | PDF ↗ |
| K171392 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2017-11-09 | Traditional | PDF ↗ |
| K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set | Bracco Injeneering | 2016-01-22 | Traditional | PDF ↗ |
| K152361 | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System | Liebel-Flarsheim Company, LLC | 2016-01-14 | Traditional | PDF ↗ |
| K091734 | SONIC SHOT GX | Nemoto Kyorindo Co., Ltd. | 2010-05-21 | Traditional | PDF ↗ |
| K063503 | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION | Mallinckrodt Inc., Liebel-Flarsheim Business | 2007-04-27 | Special | PDF ↗ |
| K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | E-Z-Em, Inc. | 2007-04-13 | Abbreviated | PDF ↗ |
| K063090 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY | Medrad, Inc. | 2007-03-27 | Traditional | PDF ↗ |
| K062265 | CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM | Swiss Medical Care S.A. | 2006-12-26 | Traditional | PDF ↗ |
| K031571 | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | E-Z-Em, Inc. | 2003-06-19 | Special | PDF ↗ |
| K983314 | PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM | Nycomed Amersham Imaging | 1999-02-19 | Traditional | PDF ↗ |
| K984058 | ACIST INJECTOR SYSTEM, MODEL CL100 H | Acist Medical Systems | 1999-02-11 | Traditional | PDF ↗ |
| K951005 | KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) | Kenex , Ltd. | 1995-05-04 | Traditional | PDF ↗ |
| K760641 | MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-10-08 | Traditional | PDF ↗ |
| K760643 | MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-10-08 | Traditional | PDF ↗ |
Product code IZQ · Class II · Cardiovascular. Data: openFDA.