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Panels › Cardiovascular › Product code DXJ · Class 2

Display, Cathode-Ray Tube, Medical

Regulation 870.2450

1510(k)s in 12 months (79 all time)
0recalls in 12 months (21 all time)
21recalls that name a 510(k)
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Top companies in DXJ

Company510(k)sRecalls
Barco N.V.62
Hewlett-Packard Co.70
Litton Medical Electronics50
Philips Healthcare Inc.05
Spacelabs Healthcare, Incorporated05
Vidco, Inc.50
Honeywell, Inc.40
Philips Medical Systems22
GE Healthcare12
Marquette Electronics, Inc.30
Decided510(k)Device and applicantCode
Sep 30, 2026K261469Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character).
Barco N.V., BE
DXJ
Nov 10, 2021K212003ESSENZ Patient Monitor
Livanova Deutschland, GmbH, DE
DXJ
Sep 30, 2021K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)
Philips Medizin Systeme Boeblingen GmbH, DE
DXJ
Aug 27, 2020K201162Essence 55SP Large Monitor System
Shenyang Torch-Bigtide Digital Technology Co., Ltd., CN
DXJ
Jul 26, 2018K173107Vios Central Station Monitor Software, Vios Central Server Software
Vios Medical, Inc.
DXJ
Jul 16, 2018K180534Philips IntelliVue GuardianSoftware
Philips Medizin Systeme Boeblingen GmbH, DE
DXJ
Feb 22, 2018K173381Nexxis OR
Barco N.V., BE
DXJ
Jan 26, 2018K172969Essence 55S Large Monitor System
Shenyang Torch-Bigtide Digital Technology Co., Ltd., CN
DXJ
Jun 8, 2017K170460Sorin Connect
Sorin Group Deutschland GmbH, DE
DXJ
Apr 21, 2017K170537Nexxis OR, Nexxis
Barco N.V., BE
DXJ
Mar 14, 2017K161880NIVR58-T kit
Barco N.V., BE
DXJ
Jan 27, 2017K161767Philips IntelliVue GuardianSoftware
Philips Medizin Systeme Boeblingen GmbH, DE
DXJ
Sep 15, 2016K162012CARESCAPE Central Station V2
GE Healthcare
DXJ
Oct 30, 2015K151366Philips CS770 IntelliSpace Critical Care and Anesthesia
Philips Medical Systems
DXJ
Oct 21, 2015K151736Philips IntelliVue GuardianSoftware
Philips Medizin Systeme Boblingen GmbH, DE
DXJ
Dec 1, 2014K133994SIVR56-T KIT
Barco N.V., BE
DXJ
Apr 30, 2014K133882CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
Ge Medical Systems Information Technologies, Inc.
DXJ
Apr 3, 2014K132488ZOLL CODE WRITER
ZOLL Medical Corporation
DXJ
Jan 3, 2014K131272SIREN EPCR SUITE
Medusa Medical Technologies, Inc.
DXJ
Dec 17, 2013K131919ZOLL EPCR IOS
ZOLL Medical Corporation
DXJ
Jul 23, 2013K131816SORIN CONNECT DATA MANAGEMENT SYSTEM
Sorin Group Deutschland GmbH, DE
DXJ
Apr 22, 2013K122167NEXXIS OR
Barco N.V., BE
DXJ
Feb 7, 2012K113214TLINK DATA MANAGEMENT SYSTEM (DMS)
Terumo Cardiovascular Systems Corp.
DXJ
Oct 4, 2011K111905INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
DXJ
Sep 22, 2011K112645RADIFORCE LARGE MONITOR SYSTEM
Eizo GmbH, DE
DXJ
May 13, 2011K103473ZOLL RESCUENET EPCR MODEL RESCUENET EPCR
ZOLL Medical Corporation
DXJ
Jan 26, 2011K110085VANTAGE VIEW SYSTEM
St Jude Medical
DXJ
Jul 2, 2010K101474MD VISION SYSTEM
Perkins Healthcare Technologies
DXJ
Apr 14, 2010K100272INTELLIVUE CLINICAL INFORMATION PORTFOLIO
Philips Medical Systems
DXJ
Nov 26, 2008K083321CARDIO-VIEW
Curlview Igt, LLC
DXJ
Dec 7, 2007K073372ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)
Systemsone
DXJ
Apr 19, 2006K053356MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
Ge Medical Systems Information Technologies
DXJ
Jan 10, 2002K013515INFINITY EXPLORER
Siemens Medical Solutions USA, Inc.
DXJ
Jun 14, 2000K001112GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC
General Electric Medical Systems Information Techn
DXJ
Aug 31, 1999K992636HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
Hewlett-Packard Co.
DXJ
Aug 12, 1997K942685ECG REVIEW STATION
Mortara Instrument, Inc.
DXJ
Jun 24, 1997K962811SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION
Spacelabs Medical, Inc.
DXJ
Jan 30, 1995K945277HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR
Hewlett-Packard Co.
DXJ
Aug 18, 1994K934093580CDR DISPLAY DRIVER
Vidco, Inc.
DXJ
Jun 20, 1994K932894620CSR DISPLAY DRIVER
Vidco, Inc.
DXJ
Dec 16, 1993K926219516YT DISPLAY DRIVER
Vidco, Inc.
DXJ
Nov 8, 1993K926162580CD DISPLAY DRIVER
Vidco, Inc.
DXJ
Nov 5, 1993K932724SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY
Spacelabs Medical, Inc.
DXJ
Jun 6, 1991K905788MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM
Hewlett-Packard Co.
DXJ
Aug 23, 1990K901072CENTRALSCOPE 12
Marquette Electronics, Inc.
DXJ
Jun 26, 1990K902334MONITOR, MODEL 2817
Esaote Biomedica Spa
DXJ
Jun 12, 1990K9018847620 REMOTE CENTRAL STATION REPEATER
Marquette Electronics, Inc.
DXJ
May 31, 1989K884423HORIZON DISPLAY CONTROLLER PART # 266-200-010
Mennen Medical, Inc.
DXJ
Mar 2, 1989K890353SMDS460 SURGICAL MONITOR DISPLAY SYSTEM
Vidco, Inc.
DXJ
Nov 9, 1988K883973MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A
Nihon Kohden America, Inc.
DXJ

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