FDA 510(k) Applications for Medical Device Product Code "DXJ"
(Display, Cathode-Ray Tube, Medical)

FDA 510(k) Number Applicant Device Name Decision Date
K173381 Barco n.v. Nexxis OR 02/22/2018
K170537 Barco n.v. Nexxis OR, Nexxis 04/21/2017
K161880 Barco N.V. NIVR58-T kit 03/14/2017
K133994 BARCO N.V. SIVR56-T KIT 12/01/2014
K122167 BARCO NV NEXXIS OR 04/22/2013
K083321 CURLVIEW IGT, LLC CARDIO-VIEW 11/26/2008
K112645 EIZO GMBH RADIFORCE LARGE MONITOR SYSTEM 09/22/2011
K162012 GE HEALTHCARE CARESCAPE Central Station V2 09/15/2016
K053356 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION 04/19/2006
K133882 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) 04/30/2014
K001112 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC 06/14/2000
K992636 HEWLETT-PACKARD CO. HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A 08/31/1999
K212003 LivaNova Deutschland GmbH ESSENZ Patient Monitor 11/10/2021
K131272 MEDUSA MEDICAL TECHNOLOGIES INC. SIREN EPCR SUITE 01/03/2014
K942685 MORTARA INSTRUMENT, INC. ECG REVIEW STATION 08/12/1997
K101474 PERKINS HEALTHCARE TECHNOLOGIES MD VISION SYSTEM 07/02/2010
K100272 PHILIPS MEDICAL SYSTEMS INTELLIVUE CLINICAL INFORMATION PORTFOLIO 04/14/2010
K151366 PHILIPS MEDICAL SYSTEMS Philips CS770 IntelliSpace Critical Care and Anesthesia 10/30/2015
K151736 PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH Philips IntelliVue GuardianSoftware 10/21/2015
K161767 PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH Philips IntelliVue GuardianSoftware 01/27/2017
K180534 Philips Medizin Systeme Boeblingen GmbH Philips IntelliVue GuardianSoftware 07/16/2018
K212208 Philips Medizin Systeme Boeblingen GmbH Philips IntelliVue GuardianSoftware (Rev. E.0X) 09/30/2021
K111905 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 10/04/2011
K172969 Shenyang Torch-Bigtide Digital Technology Co., Ltd. Essence 55S Large Monitor System 01/26/2018
K201162 Shenyang Torch-Bigtide Digital Technology Co., Ltd. Essence 55SP Large Monitor System 08/27/2020
K013515 SIEMENS MEDICAL SOLUTIONS USA, INC. INFINITY EXPLORER 01/10/2002
K170460 Sorin Group Deutschland GmbH Sorin Connect 06/08/2017
K131816 SORIN GROUP DEUTSCHLAND GMBH SORIN CONNECT DATA MANAGEMENT SYSTEM 07/23/2013
K962811 SPACELABS MEDICAL, INC. SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION 06/24/1997
K110085 ST. JUDE MEDICAL VANTAGE VIEW SYSTEM 01/26/2011
K073372 SYSTEMSONE ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) 12/07/2007
K113214 TERUMO CARDIOVASCULAR SYSTEMS CORP. TLINK DATA MANAGEMENT SYSTEM (DMS) 02/07/2012
K173107 Vios Medical, Inc. Vios Central Station Monitor Software, Vios Central Server Software 07/26/2018
K132488 ZOLL MEDICAL CORPORATION ZOLL CODE WRITER 04/03/2014
K131919 ZOLL MEDICAL CORPORATION ZOLL EPCR IOS 12/17/2013
K103473 ZOLL MEDICAL CORPORATION ZOLL RESCUENET EPCR MODEL RESCUENET EPCR 05/13/2011


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