FDA 510(k) Applications Submitted by LYNN T HARMER

FDA 510(k) Number Submission Date Device Name Applicant
K020055 01/08/2002 PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION PHILIPS MEDICAL SYSTEMS
K110151 01/18/2011 ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T PHILIPS HEALTHCARE
K050151 01/24/2005 MULTIDIAGNOST ELEVA PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K040254 02/04/2004 INTEGRIS 3D-RA, RELEASE 4.2 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K030455 02/11/2003 BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC.
K030520 02/19/2003 INTERA FAMILY PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K070528 02/23/2007 PHILIPS ESSENTA DR PHILIPS MEDICAL SYSTEMS GMBH, DMC
K090590 03/04/2009 VERADIUS, MODEL 718-130 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K090625 03/09/2009 WIRELESS PORTABLE DETECTOR FD-W17 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K050692 03/17/2005 FLXIS PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K060749 03/20/2006 XPERCT PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K070792 03/22/2007 QLAB QUANTIFICATION PHILIPS ULTRASOUND, INC.
K031333 04/28/2003 PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K111245 05/03/2011 HEARTNAVIGATOR RELEASE 1 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K101311 05/11/2010 EP NAVIGATOR R3 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K061396 05/19/2006 QLAB QUANTIFICATION SOFTWARE PHILIPS ULTRASOUND, INC.
K031597 05/21/2003 DUNLEE FORMAT COLLIMATOR FAMILY PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K031815 06/12/2003 INTERA-SENSATION FAMILY PHILIPS MEDICAL SYSTEMS
K032046 07/02/2003 PHILLIPS OMNIDIAGNOST ELEVA PHILIPS MEDICAL SYSTEMS, INC.
K102005 07/15/2010 ALLURA XPER OR TABLE SERIES PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K041949 07/20/2004 ALLURA XPER FD10 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K052078 08/01/2005 ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K102344 08/18/2010 MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K042334 08/30/2004 ALLURA 3D-CA, RELEASE 1 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K042368 08/31/2004 PRACTIX CONVENIO PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K022899 09/03/2002 PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K062650 09/07/2006 EP NAVIGATOR SOFTWARE PHILIPS MEDICAL SYSTEMS
K023137 09/20/2002 PHILIPS EASYVISION WORKSTATION RELEASE 6 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K042540 09/20/2004 PHILIPS IU22 ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC.
K023440 10/15/2002 PHILIPS DIGITAL IMAGING OPTION RELEASE 1 PHILIPS MEDICAL SYSTEMS
K023441 10/15/2002 PHILIPS MULTIDIAGNOST ELEVA PHILIPS MEDICAL SYSTEMS
K093355 10/27/2009 PCR ELEVA 1.2 PHILIPS MEDICAL SYSTEMS, INC.
K023877 11/21/2002 Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN PHILIPS ULTRASOUND, INC.
K013894 11/23/2001 TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K033737 11/28/2003 ALLURA XPER FD20 PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K083740 12/16/2008 MAMMODIAGNOST VU PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K063781 12/21/2006 PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K034003 12/24/2003 HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC.
K031535 05/16/2003 PHILIPS EASYDIAGNOST ELEVA PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K031836 06/13/2003 PHILIPS FRESCO RELEASE 1 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K032096 07/08/2003 PHILIPS VIEWFORUM 2003 PHILIPS MEDICAL SYSTEMS
K061995 07/14/2006 XCELERA PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K052013 07/26/2005 ACHIEVA 1.5T & INERA 1.5T FAMILY PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K022788 08/22/2002 PHILIPS HARMONY RELEASE 1 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K042867 10/18/2004 PHILIPS ORTHOPAEDIC APPLICATIONS PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K043147 11/15/2004 ACHIEVA FAMILY PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.


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