DXJ · Class II · 21 CFR 870.2450

FDA Product Code DXJ: Display, Cathode-ray Tube, Medical

Leading manufacturers include Hewlett-Packard Co., Barco N.V. and Litton Medical Electronics.

78
Total
78
Cleared
132d
Avg days
1976
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Display, Cathode-ray Tube, Medical Devices (Product Code DXJ)

78 devices
1–24 of 78
Cleared Nov 10, 2021
ESSENZ Patient Monitor
K212003
Livanova Deutschland, GmbH
Cardiovascular · 135d
Cleared Sep 30, 2021
Philips IntelliVue GuardianSoftware (Rev. E.0X)
K212208
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 77d
Cleared Aug 27, 2020
Essence 55SP Large Monitor System
K201162
Shenyang Torch-Bigtide Digital Technology Co., Ltd.
Cardiovascular · 119d
Cleared Jul 26, 2018
Vios Central Station Monitor Software, Vios Central Server Software
K173107
Vios Medical, Inc.
Cardiovascular · 300d
Cleared Jul 16, 2018
Philips IntelliVue GuardianSoftware
K180534
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 138d
Cleared Feb 22, 2018
Nexxis OR
K173381
Barco N.V.
Cardiovascular · 115d
Cleared Jan 26, 2018
Essence 55S Large Monitor System
K172969
Shenyang Torch-Bigtide Digital Technology Co., Ltd.
Cardiovascular · 122d
Cleared Jun 08, 2017
Sorin Connect
K170460
Sorin Group Deutschland GmbH
Cardiovascular · 113d
Cleared Apr 21, 2017
Nexxis OR, Nexxis
K170537
Barco N.V.
Cardiovascular · 57d
Cleared Mar 14, 2017
NIVR58-T kit
K161880
Barco N.V.
Cardiovascular · 249d
Cleared Jan 27, 2017
Philips IntelliVue GuardianSoftware
K161767
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 214d
Cleared Sep 15, 2016
CARESCAPE Central Station V2
K162012
Ge Healthcare
Cardiovascular · 56d
Cleared Oct 30, 2015
Philips CS770 IntelliSpace Critical Care and Anesthesia
K151366
Philips Medical Systems
Cardiovascular · 162d
Cleared Oct 21, 2015
Philips IntelliVue GuardianSoftware
K151736
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 117d
Cleared Dec 01, 2014
SIVR56-T KIT
K133994
Barco N.V.
Cardiovascular · 340d
Cleared Apr 30, 2014
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
K133882
Ge Medical Systems Information Technologies, Inc.
Cardiovascular · 131d
Cleared Apr 03, 2014
ZOLL CODE WRITER
K132488
ZOLL Medical Corporation
Cardiovascular · 238d
Cleared Jan 03, 2014
SIREN EPCR SUITE
K131272
Medusa Medical Technologies, Inc.
Cardiovascular · 245d
Cleared Dec 17, 2013
ZOLL EPCR IOS
K131919
ZOLL Medical Corporation
Cardiovascular · 174d
Cleared Jul 23, 2013
SORIN CONNECT DATA MANAGEMENT SYSTEM
K131816
Sorin Group Deutschland GmbH
Cardiovascular · 33d
Cleared Apr 22, 2013
NEXXIS OR
K122167
Barco N.V.
Cardiovascular · 273d
Cleared Feb 07, 2012
TLINK DATA MANAGEMENT SYSTEM (DMS)
K113214
Terumo Cardiovascular Systems Corp.
Cardiovascular · 99d
Cleared Oct 04, 2011
INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216
K111905
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Cardiovascular · 91d
Cleared Sep 22, 2011
RADIFORCE LARGE MONITOR SYSTEM
K112645
Eizo GmbH
Cardiovascular · 10d

About Product Code DXJ - Regulatory Context

510(k) Submission Activity

78 total 510(k) submissions under product code DXJ since 1976, with 78 receiving FDA clearance (average review time: 132 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.