FDA 510(k) Applications Submitted by MEDRAD, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K130381 02/14/2013 ANGIOJET ULTRA POWER PULSE KIT MEDRAD, INC.
K031483 05/12/2003 MEDRAD MANUAL SYRINGE LOADER MEDRAD, INC.
K031808 06/12/2003 MEDRAD SWABBABLE VALVE TRANSFER SET MEDRAD, INC.
K032771 09/08/2003 MEDRAD CONTINUUM MR INFUSION SYSTEM MEDRAD, INC.
K133023 09/26/2013 JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 MEDRAD, INC.
K130637 03/11/2013 JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM MEDRAD, INC.
K122916 09/21/2012 JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM MEDRAD, INC.
K111182 04/27/2011 ANGIOJET SOLENT OMNI THROMBECTOMY SET MEDRAD, INC.
K082458 08/26/2008 P3T ABDOMEN MEDRAD, INC.
K082905 09/30/2008 MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC MEDRAD, INC.
K001663 05/31/2000 FRONT-LOAD POLYPROPYLENE SYRINGE MEDRAD, INC.
K022431 07/25/2002 MEDRAD TRANSFER SET MEDRAD, INC.
K023183 09/24/2002 MEDRAD STELLANT CT INJECTOR SYSTEM MEDRAD, INC.
K013815 11/16/2001 MEDRAD QWIK-FIT SYRINGE MEDRAD, INC.
K984418 12/10/1998 UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET MEDRAD, INC.
K050371 02/14/2005 MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER MEDRAD, INC.
K050456 02/23/2005 MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM MEDRAD, INC.
K991557 05/04/1999 MEDRAD VISTRON CT INJECTOR SYSTEM MEDRAD, INC.
K982814 08/11/1998 MEDRAD VISTRON CT INJECTOR SYSTEM MEDRAD, INC.
K993728 11/04/1999 MEDRAD ENVISION CT INJECTOR SYSTEM MEDRAD, INC.
K982932 08/20/1998 MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC MEDRAD, INC.
K023596 10/28/2002 MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL MEDRAD, INC.
K982959 08/24/1998 MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC MEDRAD, INC.
K984159 11/19/1998 MEDRAD QUADRATURE CTL ARRAY COIL MEDRAD, INC.
K982921 08/19/1998 MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA MEDRAD, INC.
K982916 08/19/1998 MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC MEDRAD, INC.
K982919 08/19/1998 MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC MEDRAD, INC.
K984257 11/30/1998 MEDRAD PHASED ARRAY NEUROVASCULAR COIL MEDRAD, INC.
K061128 04/24/2006 MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM MEDRAD, INC.
K042784 10/06/2004 MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM MEDRAD, INC.
K073051 10/29/2007 MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY MEDRAD, INC.
K060401 02/15/2006 MEDRAD 3.0T ECOIL IMAGING SYSTEM MEDRAD, INC.
K051349 05/24/2005 3.0T PROSTATE IMAGING SYSTEM MEDRAD, INC.
K052827 10/05/2005 MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS MEDRAD, INC.
K053042 10/28/2005 MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE MEDRAD, INC.
K063342 11/06/2006 MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS MEDRAD, INC.
K072886 10/09/2007 MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T MEDRAD, INC.
K021988 06/18/2002 MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM MEDRAD, INC.
K011991 06/26/2001 MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR MEDRAD, INC.
K012950 09/04/2001 MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM MEDRAD, INC.
K973787 10/06/1997 MEDRAD 1.5T EXTREMITY ARRAY MEDRAD, INC.
K974308 11/17/1997 MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY MEDRAD, INC.
K964642 11/19/1996 MEDRAD DISPOSABLE SYRINGES MEDRAD, INC.
K974438 11/24/1997 MEDRAD ATD-T INTERFACE DEVICE MEDRAD, INC.
K112086 07/21/2011 MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE MEDRAD, INC.
K113133 10/24/2011 MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE MEDRAD, INC.
K113363 11/15/2011 ANGIOJET SOLENT DISTA THROMBECTOMY SET MEDRAD, INC.
K113428 11/21/2011 ANGIOJET ULTRA DVX THROMBECTOMY SET MEDRAD, INC.
K960901 03/05/1996 MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL MEDRAD, INC.
K981094 03/26/1998 MEDRAD NEUROVASCULAR COIL MEDRAD, INC.
K971380 04/14/1997 MEDRAD FLEX INTERFACE DEVICE MEDRAD, INC.
K954952 10/30/1995 MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL MEDRAD, INC.
K964854 12/03/1996 MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL MEDRAD, INC.
K955626 12/11/1995 MEDRAD/HITACHI BREAST IMAGING SURFACE COIL MEDRAD, INC.
K980417 02/03/1998 MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V MEDRAD, INC.
K964782 11/27/1996 MEDRAD CONTRAST HOLDER MEDRAD, INC.
K100798 03/22/2010 MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C MEDRAD, INC.
K080297 02/04/2008 MEDRAD INTEGO PET INFUSION SYSTEM MEDRAD, INC.
K033247 10/07/2003 MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM MEDRAD, INC.
K063090 10/10/2006 MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY MEDRAD, INC.
K033881 12/15/2003 MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE MEDRAD, INC.


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