Product Code: DXJ FDA class 2 21 CFR 870.2450

Display, Cathode-Ray Tube, Medical

Cardiovascular

The Medical Cathode-Ray Tube Display is a cardiovascular electronic display device used to visually present physiological waveforms, numerical data, or diagnostic images from monitoring or imaging equipment at the point of care or on a medical workstation. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DXJ and it is regulated under 21 CFR 870.2450 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: DXJ
Device Class: FDA class 2
Regulation Number: 870.2450
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 78 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K212003	ESSENZ Patient Monitor	Nov 10, 2021	Substantially Equivalent	Livanova Deutschland, GmbH
K212208	Philips IntelliVue GuardianSoftware (Rev. E.0X)	Sep 30, 2021	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K201162	Essence 55SP Large Monitor System	Aug 27, 2020	Substantially Equivalent	Shenyang Torch-Bigtide Digital Technology Co., Ltd.
K173107	Vios Central Station Monitor Software, Vios Central Server Software	Jul 26, 2018	Substantially Equivalent	Vios Medical, Inc.
K180534	Philips IntelliVue GuardianSoftware	Jul 16, 2018	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K173381	Nexxis OR	Feb 22, 2018	Substantially Equivalent	Barco N.V.
K172969	Essence 55S Large Monitor System	Jan 26, 2018	Substantially Equivalent	Shenyang Torch-Bigtide Digital Technology Co., Ltd.
K170460	Sorin Connect	Jun 08, 2017	Substantially Equivalent	Sorin Group Deutschland GmbH
K170537	Nexxis OR, Nexxis	Apr 21, 2017	Substantially Equivalent	Barco N.V.
K161880	NIVR58-T kit	Mar 14, 2017	Substantially Equivalent	Barco N.V.
K161767	Philips IntelliVue GuardianSoftware	Jan 27, 2017	Substantially Equivalent	Philips Medizin Systeme Boeblingen GmbH
K162012	CARESCAPE Central Station V2	Sep 15, 2016	Substantially Equivalent	GE Healthcare
K151366	Philips CS770 IntelliSpace Critical Care and Anesthesia	Oct 30, 2015	Substantially Equivalent	Philips Medical Systems
K151736	Philips IntelliVue GuardianSoftware	Oct 21, 2015	Substantially Equivalent	Philips Medizin Systeme Boblingen GmbH
K133994	SIVR56-T KIT	Dec 01, 2014	Substantially Equivalent	Barco N.V.
K133882	CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)	Apr 30, 2014	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K132488	ZOLL CODE WRITER	Apr 03, 2014	Substantially Equivalent	ZOLL Medical Corporation
K131272	SIREN EPCR SUITE	Jan 03, 2014	Substantially Equivalent	Medusa Medical Technologies, Inc.
K131919	ZOLL EPCR IOS	Dec 17, 2013	Substantially Equivalent	ZOLL Medical Corporation
K131816	SORIN CONNECT DATA MANAGEMENT SYSTEM	Jul 23, 2013	Substantially Equivalent	Sorin Group Deutschland GmbH
K122167	NEXXIS OR	Apr 22, 2013	Substantially Equivalent	Barco N.V.
K113214	TLINK DATA MANAGEMENT SYSTEM (DMS)	Feb 07, 2012	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K111905	INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216	Oct 04, 2011	Substantially Equivalent	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
K112645	RADIFORCE LARGE MONITOR SYSTEM	Sep 22, 2011	Substantially Equivalent	Eizo GmbH
K103473	ZOLL RESCUENET EPCR MODEL RESCUENET EPCR	May 13, 2011	Substantially Equivalent	ZOLL Medical Corporation
K110085	VANTAGE VIEW SYSTEM	Jan 26, 2011	Substantially Equivalent	St Jude Medical
K101474	MD VISION SYSTEM	Jul 02, 2010	Substantially Equivalent	Perkins Healthcare Technologies
K100272	INTELLIVUE CLINICAL INFORMATION PORTFOLIO	Apr 14, 2010	Substantially Equivalent	Philips Medical Systems
K083321	CARDIO-VIEW	Nov 26, 2008	Substantially Equivalent	Curlview Igt, LLC
K073372	ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)	Dec 07, 2007	Substantially Equivalent	Systemsone
K053356	MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION	Apr 19, 2006	Substantially Equivalent	Ge Medical Systems Information Technologies
K013515	INFINITY EXPLORER	Jan 10, 2002	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K001112	GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC	Jun 14, 2000	Substantially Equivalent	General Electric Medical Systems Information Techn
K992636	HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A	Aug 31, 1999	Substantially Equivalent	Hewlett-Packard Co.
K942685	ECG REVIEW STATION	Aug 12, 1997	Substantially Equivalent	Mortara Instrument, Inc.
K962811	SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION	Jun 24, 1997	Substantially Equivalent	Spacelabs Medical, Inc.
K945277	HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR	Jan 30, 1995	Substantially Equivalent	Hewlett-Packard Co.
K934093	580CDR DISPLAY DRIVER	Aug 18, 1994	Substantially Equivalent	Vidco, Inc.
K932894	620CSR DISPLAY DRIVER	Jun 20, 1994	Substantially Equivalent	Vidco, Inc.
K926219	516YT DISPLAY DRIVER	Dec 16, 1993	Substantially Equivalent	Vidco, Inc.
K926162	580CD DISPLAY DRIVER	Nov 08, 1993	Substantially Equivalent	Vidco, Inc.
K932724	SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY	Nov 05, 1993	Substantially Equivalent	Spacelabs Medical, Inc.
K905788	MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM	Jun 06, 1991	Substantially Equivalent	Hewlett-Packard Co.
K901072	CENTRALSCOPE 12	Aug 23, 1990	Substantially Equivalent	Marquette Electronics, Inc.
K902334	MONITOR, MODEL 2817	Jun 26, 1990	Substantially Equivalent	Esaote Biomedica Spa
K901884	7620 REMOTE CENTRAL STATION REPEATER	Jun 12, 1990	Substantially Equivalent	Marquette Electronics, Inc.
K884423	HORIZON DISPLAY CONTROLLER PART # 266-200-010	May 31, 1989	Substantially Equivalent	Mennen Medical, Inc.
K890353	SMDS460 SURGICAL MONITOR DISPLAY SYSTEM	Mar 02, 1989	Substantially Equivalent	Vidco, Inc.
K883973	MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A	Nov 09, 1988	Substantially Equivalent	Nihon Kohden America, Inc.
K883031	Q-CATH RM	Sep 20, 1988	Substantially Equivalent	Quinton, Inc.
K873774	M300 MONITOR/CONTROLLER T500 TREADMILL	Nov 06, 1987	Substantially Equivalent	Burdick Corp.
K854372	VM 781 SLAVE SCOPE	Feb 28, 1986	Substantially Equivalent	Nihon Kohden America, Inc.
K851496	ECG MONITOR MODEL RM102	Jul 24, 1985	Substantially Equivalent	Honeywell, Inc.
K851628	RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO	Jun 27, 1985	Substantially Equivalent	Eaton Medical Group
K851400	SIRECUST 420 PATIENT DIALOG MONITOR	Jun 26, 1985	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K850343	DISPLAY MONITOR (VD-711RA-VD-712RA)	Apr 18, 1985	Substantially Equivalent	Nihon Kohden America, Inc.
K844650	DR-2C	Jan 22, 1985	Substantially Equivalent	General Devices
K840209	SERVOMED MEDIVISION SCOPE SMV-235	Sep 20, 1984	Substantially Equivalent	Litton Medical Electronics
K833819	M305	May 09, 1984	Substantially Equivalent	Burkick Corp.
K832022	SERVOMED SMC 108/111-426-24, 111-426	Nov 16, 1983	Substantially Equivalent	Litton Medical Electronics
K831783	SERVOMED BASIC BEDSIDE UNIT SMV 104	Nov 16, 1983	Substantially Equivalent	Litton Medical Electronics
K831782	SERVOMED BASIC BEDSIDE UNIT SMV 107	Nov 16, 1983	Substantially Equivalent	Litton Medical Electronics
K831781	SERVOMED BASIC BEDSIDE UNIT SMVIII W	Nov 16, 1983	Substantially Equivalent	Litton Medical Electronics
K830899	THREE CHANNEL MONITOR SERIES 6700	Apr 12, 1983	Substantially Equivalent	Marquette Electronics, Inc.
K822517	SINGLE CHANNEL NONFADE OSCILLOSCOPE	Sep 14, 1982	Substantially Equivalent	Quinton, Inc.
K821491	35MM ANGIOGRAM VIEWER ANALYZER	Jul 08, 1982	Substantially Equivalent	Birtcher Corp.
K811911	SINGLE CHANNEL NON-FADE OSCILLOSCOPE	Jul 28, 1981	Substantially Equivalent	Quinton, Inc.
K810168	SLAVE MONITORS DC109 & VS109	Feb 25, 1981	Substantially Equivalent	Honeywell, Inc.
K810165	DUAL TRACE VIDEO MONITOR VM 410	Feb 25, 1981	Substantially Equivalent	Honeywell, Inc.
K810164	VC 430 VIDEO CONVERTER	Feb 25, 1981	Substantially Equivalent	Honeywell, Inc.
K803123	CRT DISPLAY #1310B	Jan 13, 1981	Substantially Equivalent	Hewlett-Packard Co.
K801000	LARGE SCREEN CRT DISPLAY #1311B	May 28, 1980	Substantially Equivalent	Hewlett-Packard Co.
K781256	CATHODE RAY TUBE MED. DISPLAY	Sep 20, 1978	Substantially Equivalent	Rae Medical Corp.
K780782	M. 1336S CATHODE-RAY TUBE DISPLAY	Jun 14, 1978	Substantially Equivalent	Hewlett-Packard Co.
K780425	BIOPHYSICAL MONITORING SYSTEM	Apr 28, 1978	Substantially Equivalent	Gould, Inc.
K770279	MONITOR, PORTABLE, PART #431-010	Feb 24, 1977	Substantially Equivalent	Mennen Greatbatch Electonics
K760721	MEDICAL OSCILLOSCOPE MEMORY SCOPE	Oct 06, 1976	Substantially Equivalent	Abbott Laboratories
K760523	MONITOR SCOPE	Sep 03, 1976	Substantially Equivalent	Hewlett-Packard Co.