Atlas FDA

DXJ

78 FDA 510(k) clearances · Product code

94 daysmedian time to decision
300 days90th percentile
78clearances measured

FDA profile

Official device name
Display, Cathode-Ray Tube, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2450
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2015: 15 · 2017: 10 · 2019: 29 · 2020: 22 · 2023: 17 · 2026: 35
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ESSENZ Patient Monitor (K212003)Livanova Deutschland, GmbH2021-11-10
Philips IntelliVue GuardianSoftware (Rev. E.0X) (K212208)Philips Medizin Systeme Boeblingen GmbH2021-09-30
Essence 55SP Large Monitor System (K201162)Shenyang Torch-Bigtide Digital Technology Co., Ltd.2020-08-27
Vios Central Station Monitor Software, Vios Central Server Software (K173107)Vios Medical, Inc.2018-07-26
Philips IntelliVue GuardianSoftware (K180534)Philips Medizin Systeme Boeblingen GmbH2018-07-16
Nexxis OR (K173381)Barco N.V.2018-02-22
Essence 55S Large Monitor System (K172969)Shenyang Torch-Bigtide Digital Technology Co., Ltd.2018-01-26
Sorin Connect (K170460)Sorin Group Deutschland GmbH2017-06-08
Nexxis OR, Nexxis (K170537)Barco N.V.2017-04-21
NIVR58-T kit (K161880)Barco N.V.2017-03-14
Philips IntelliVue GuardianSoftware (K161767)Philips Medizin Systeme Boeblingen GmbH2017-01-27
CARESCAPE Central Station V2 (K162012)GE Healthcare2016-09-15
Philips CS770 IntelliSpace Critical Care and Anesthesia (K151366)Philips Medical Systems2015-10-30
Philips IntelliVue GuardianSoftware (K151736)Philips Medizin Systeme Boblingen GmbH2015-10-21
SIVR56-T KIT (K133994)Barco N.V.2014-12-01
CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) (K133882)Ge Medical Systems Information Technologies, Inc.2014-04-30
ZOLL CODE WRITER (K132488)ZOLL Medical Corporation2014-04-03
SIREN EPCR SUITE (K131272)Medusa Medical Technologies, Inc.2014-01-03
ZOLL EPCR IOS (K131919)ZOLL Medical Corporation2013-12-17
SORIN CONNECT DATA MANAGEMENT SYSTEM (K131816)Sorin Group Deutschland GmbH2013-07-23
NEXXIS OR (K122167)Barco N.V.2013-04-22
TLINK DATA MANAGEMENT SYSTEM (DMS) (K113214)Terumo Cardiovascular Systems Corp.2012-02-07
INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 (K111905)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011-10-04
RADIFORCE LARGE MONITOR SYSTEM (K112645)Eizo GmbH2011-09-22
ZOLL RESCUENET EPCR MODEL RESCUENET EPCR (K103473)ZOLL Medical Corporation2011-05-13
VANTAGE VIEW SYSTEM (K110085)St Jude Medical2011-01-26
MD VISION SYSTEM (K101474)Perkins Healthcare Technologies2010-07-02
INTELLIVUE CLINICAL INFORMATION PORTFOLIO (K100272)Philips Medical Systems2010-04-14
CARDIO-VIEW (K083321)Curlview Igt, LLC2008-11-26
ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) (K073372)Systemsone2007-12-07
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION (K053356)Ge Medical Systems Information Technologies2006-04-19
INFINITY EXPLORER (K013515)Siemens Medical Solutions USA, Inc.2002-01-10
GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC (K001112)General Electric Medical Systems Information Techn2000-06-14
HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A (K992636)Hewlett-Packard Co.1999-08-31
ECG REVIEW STATION (K942685)Mortara Instrument, Inc.1997-08-12
SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION (K962811)Spacelabs Medical, Inc.1997-06-24
HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR (K945277)Hewlett-Packard Co.1995-01-30
580CDR DISPLAY DRIVER (K934093)Vidco, Inc.1994-08-18
620CSR DISPLAY DRIVER (K932894)Vidco, Inc.1994-06-20
516YT DISPLAY DRIVER (K926219)Vidco, Inc.1993-12-16
580CD DISPLAY DRIVER (K926162)Vidco, Inc.1993-11-08
SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY (K932724)Spacelabs Medical, Inc.1993-11-05
MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM (K905788)Hewlett-Packard Co.1991-06-06
CENTRALSCOPE 12 (K901072)Marquette Electronics, Inc.1990-08-23
MONITOR, MODEL 2817 (K902334)Esaote Biomedica Spa1990-06-26
7620 REMOTE CENTRAL STATION REPEATER (K901884)Marquette Electronics, Inc.1990-06-12
HORIZON DISPLAY CONTROLLER PART # 266-200-010 (K884423)Mennen Medical, Inc.1989-05-31
SMDS460 SURGICAL MONITOR DISPLAY SYSTEM (K890353)Vidco, Inc.1989-03-02
MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A (K883973)Nihon Kohden America, Inc.1988-11-09
Q-CATH RM (K883031)Quinton, Inc.1988-09-20
M300 MONITOR/CONTROLLER T500 TREADMILL (K873774)Burdick Corp.1987-11-06
VM 781 SLAVE SCOPE (K854372)Nihon Kohden America, Inc.1986-02-28
ECG MONITOR MODEL RM102 (K851496)Honeywell, Inc.1985-07-24
RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO (K851628)Eaton Medical Group1985-06-27
SIRECUST 420 PATIENT DIALOG MONITOR (K851400)Siemens Medical Solutions USA, Inc.1985-06-26
DISPLAY MONITOR (VD-711RA-VD-712RA) (K850343)Nihon Kohden America, Inc.1985-04-18
DR-2C (K844650)General Devices1985-01-22
SERVOMED MEDIVISION SCOPE SMV-235 (K840209)Litton Medical Electronics1984-09-20
M305 (K833819)Burkick Corp.1984-05-09
SERVOMED BASIC BEDSIDE UNIT SMVIII W (K831781)Litton Medical Electronics1983-11-16
SERVOMED BASIC BEDSIDE UNIT SMV 104 (K831783)Litton Medical Electronics1983-11-16
SERVOMED SMC 108/111-426-24, 111-426 (K832022)Litton Medical Electronics1983-11-16
SERVOMED BASIC BEDSIDE UNIT SMV 107 (K831782)Litton Medical Electronics1983-11-16
THREE CHANNEL MONITOR SERIES 6700 (K830899)Marquette Electronics, Inc.1983-04-12
SINGLE CHANNEL NONFADE OSCILLOSCOPE (K822517)Quinton, Inc.1982-09-14
35MM ANGIOGRAM VIEWER ANALYZER (K821491)Birtcher Corp.1982-07-08
SINGLE CHANNEL NON-FADE OSCILLOSCOPE (K811911)Quinton, Inc.1981-07-28
DUAL TRACE VIDEO MONITOR VM 410 (K810165)Honeywell, Inc.1981-02-25
SLAVE MONITORS DC109 & VS109 (K810168)Honeywell, Inc.1981-02-25
VC 430 VIDEO CONVERTER (K810164)Honeywell, Inc.1981-02-25
CRT DISPLAY #1310B (K803123)Hewlett-Packard Co.1981-01-13
LARGE SCREEN CRT DISPLAY #1311B (K801000)Hewlett-Packard Co.1980-05-28
CATHODE RAY TUBE MED. DISPLAY (K781256)Rae Medical Corp.1978-09-20
M. 1336S CATHODE-RAY TUBE DISPLAY (K780782)Hewlett-Packard Co.1978-06-14
BIOPHYSICAL MONITORING SYSTEM (K780425)Gould, Inc.1978-04-28
MONITOR, PORTABLE, PART #431-010 (K770279)Mennen Greatbatch Electonics1977-02-24
MEDICAL OSCILLOSCOPE MEMORY SCOPE (K760721)Abbott Laboratories1976-10-06
MONITOR SCOPE (K760523)Hewlett-Packard Co.1976-09-03

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Every clearance here is in the API, with alerts when new ones post.