FDA 510(k) Applications for Medical Device Product Code "IZQ"
(Injector, Contrast Medium, Automatic)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K984058 |
ACIST MEDICAL SYSTEMS |
ACIST INJECTOR SYSTEM, MODEL CL100 H |
02/11/1999 |
K151048 |
BRACCO INJENEERING |
CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set |
01/22/2016 |
K031571 |
E-Z-EM, INC. |
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 |
06/19/2003 |
K062449 |
E-Z-EM, INC. |
EMPOWERMR INJECTOR SYSTEM, MODEL 9730 |
04/13/2007 |
K152361 |
Liebel-Flarsheim Company LLC |
OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System |
01/14/2016 |
K063503 |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION |
04/27/2007 |
K063090 |
MEDRAD, INC. |
MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY |
03/27/2007 |
K091734 |
NEMOTO KYORINDO CO., LTD. |
SONIC SHOT GX |
05/21/2010 |
K983314 |
NYCOMED AMERSHAM IMAGING |
PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM |
02/19/1999 |
K062265 |
SWISS MEDICAL CARE S.A. |
CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM |
12/26/2006 |
K171392 |
ulrich GmbH & Co. KG |
ulrichINJECT CT motion |
11/09/2017 |
K192872 |
ulrich GmbH & Co. KG |
ulrichINJECT CT Motion |
07/02/2020 |
K210541 |
ulrich GmbH & Co. KG |
ulrichINJECT CT motion |
08/06/2021 |
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