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.

79
Total
79
Cleared
132d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 149d avg (recent)

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

79 devices
1–24 of 79
Cleared Sep 30, 2026
Nexxis 2
K261469
Barco N.V.
General & Plastic Surgery · 149d
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

About Product Code DXJ - Regulatory Context

510(k) Submission Activity

79 total 510(k) submissions under product code DXJ since 1976, with 79 receiving FDA clearance (average review time: 132 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DXJ Product Code

FDA review times for DXJ submissions have been consistent, averaging 149 days recently vs 132 days historically.

DXJ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →