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

FDA 510(k) Number Applicant Device Name Decision Date
K760721 ABBOTT LABORATORIES MEDICAL OSCILLOSCOPE MEMORY SCOPE 10/06/1976
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
K821491 BIRTCHER CORP. 35MM ANGIOGRAM VIEWER ANALYZER 07/08/1982
K873774 BURDICK CORP. M300 MONITOR/CONTROLLER T500 TREADMILL 11/06/1987
K833819 BURKICK CORP. M305 05/09/1984
K083321 CURLVIEW IGT, LLC CARDIO-VIEW 11/26/2008
K851628 EATON MEDICAL GROUP RMG-9 9" REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO 06/27/1985
K112645 EIZO GMBH RADIFORCE LARGE MONITOR SYSTEM 09/22/2011
K902334 ESAOTE BIOMEDICA SPA MONITOR, MODEL 2817 06/26/1990
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
K844650 GENERAL DEVICES DR-2C 01/22/1985
K001112 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC 06/14/2000
K780425 GOULD, INC. BIOPHYSICAL MONITORING SYSTEM 04/28/1978
K803123 HEWLETT-PACKARD CO. CRT DISPLAY #1310B 01/13/1981
K945277 HEWLETT-PACKARD CO. HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR 01/30/1995
K992636 HEWLETT-PACKARD CO. HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A 08/31/1999
K801000 HEWLETT-PACKARD CO. LARGE SCREEN CRT DISPLAY #1311B 05/28/1980
K780782 HEWLETT-PACKARD CO. M. 1336S CATHODE-RAY TUBE DISPLAY 06/14/1978
K905788 HEWLETT-PACKARD CO. MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM 06/06/1991
K760523 HEWLETT-PACKARD CO. MONITOR SCOPE 09/03/1976
K810165 HONEYWELL, INC. DUAL TRACE VIDEO MONITOR VM 410 02/25/1981
K851496 HONEYWELL, INC. ECG MONITOR MODEL RM102 07/24/1985
K810168 HONEYWELL, INC. SLAVE MONITORS DC109 & VS109 02/25/1981
K810164 HONEYWELL, INC. VC 430 VIDEO CONVERTER 02/25/1981
K831783 LITTON MEDICAL ELECTRONICS SERVOMED BASIC BEDSIDE UNIT SMV 104 11/16/1983
K831782 LITTON MEDICAL ELECTRONICS SERVOMED BASIC BEDSIDE UNIT SMV 107 11/16/1983
K831781 LITTON MEDICAL ELECTRONICS SERVOMED BASIC BEDSIDE UNIT SMVIII W 11/16/1983
K840209 LITTON MEDICAL ELECTRONICS SERVOMED MEDIVISION SCOPE SMV-235 09/20/1984
K832022 LITTON MEDICAL ELECTRONICS SERVOMED SMC 108/111-426-24, 111-426 11/16/1983
K901884 MARQUETTE ELECTRONICS, INC. 7620 REMOTE CENTRAL STATION REPEATER 06/12/1990
K901072 MARQUETTE ELECTRONICS, INC. CENTRALSCOPE 12 08/23/1990
K830899 MARQUETTE ELECTRONICS, INC. THREE CHANNEL MONITOR SERIES 6700 04/12/1983
K131272 MEDUSA MEDICAL TECHNOLOGIES INC. SIREN EPCR SUITE 01/03/2014
K770279 MENNEN GREATBATCH ELECTONICS MONITOR, PORTABLE, PART #431-010 02/24/1977
K884423 MENNEN MEDICAL, INC. HORIZON DISPLAY CONTROLLER PART # 266-200-010 05/31/1989
K883718 MERIT MEDICAL SYSTEMS, INC. MERIT HI-FLEX(TM) 01/30/1989
K942685 MORTARA INSTRUMENT, INC. ECG REVIEW STATION 08/12/1997
K850343 NIHON KOHDEN AMERICA, INC. DISPLAY MONITOR (VD-711RA-VD-712RA) 04/18/1985
K883973 NIHON KOHDEN AMERICA, INC. MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A 11/09/1988
K854372 NIHON KOHDEN AMERICA, INC. VM 781 SLAVE SCOPE 02/28/1986
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
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
K883031 QUINTON, INC. Q-CATH RM 09/20/1988
K811911 QUINTON, INC. SINGLE CHANNEL NON-FADE OSCILLOSCOPE 07/28/1981
K822517 QUINTON, INC. SINGLE CHANNEL NONFADE OSCILLOSCOPE 09/14/1982
K781256 RAE MEDICAL CORP. CATHODE RAY TUBE MED. DISPLAY 09/20/1978
K172969 Shenyang Torch-Bigtide Digital Technology Co., Ltd. Essence 55S Large Monitor System 01/26/2018
K013515 SIEMENS MEDICAL SOLUTIONS USA, INC. INFINITY EXPLORER 01/10/2002
K851400 SIEMENS MEDICAL SOLUTIONS USA, INC. SIRECUST 420 PATIENT DIALOG MONITOR 06/26/1985
K170460 Sorin Group Deutschland GmbH Sorin Connect 06/08/2017
K131816 SORIN GROUP DEUTSCHLAND GMBH SORIN CONNECT DATA MANAGEMENT SYSTEM 07/23/2013
K932724 SPACELABS MEDICAL, INC. SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY 11/05/1993
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
K926219 VIDCO, INC. 516YT DISPLAY DRIVER 12/16/1993
K926162 VIDCO, INC. 580CD DISPLAY DRIVER 11/08/1993
K934093 VIDCO, INC. 580CDR DISPLAY DRIVER 08/18/1994
K932894 VIDCO, INC. 620CSR DISPLAY DRIVER 06/20/1994
K890353 VIDCO, INC. SMDS460 SURGICAL MONITOR DISPLAY SYSTEM 03/02/1989
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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