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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