Product code DXJ
- Device name
- Display, Cathode-Ray Tube, Medical
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2450
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212003 | ESSENZ Patient Monitor | Livanova Deutschland, GmbH | 2021-11-10 |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Philips Medizin Systeme Boeblingen GmbH | 2021-09-30 |
| K201162 | Essence 55SP Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2020-08-27 |
| K173107 | Vios Central Station Monitor Software, Vios Central Server Software | Vios Medical, Inc. | 2018-07-26 |
| K180534 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2018-07-16 |
| K173381 | Nexxis OR | Barco N.V. | 2018-02-22 |
| K172969 | Essence 55S Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2018-01-26 |
| K170460 | Sorin Connect | Sorin Group Deutschland GmbH | 2017-06-08 |
| K170537 | Nexxis OR, Nexxis | Barco N.V. | 2017-04-21 |
| K161880 | NIVR58-T kit | Barco N.V. | 2017-03-14 |
| K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017-01-27 |
| K162012 | CARESCAPE Central Station V2 | GE Healthcare | 2016-09-15 |
| K151366 | Philips CS770 IntelliSpace Critical Care and Anesthesia | Philips Medical Systems | 2015-10-30 |
| K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015-10-21 |
| K133994 | SIVR56-T KIT | Barco N.V. | 2014-12-01 |
| K133882 | CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) | Ge Medical Systems Information Technologies, Inc. | 2014-04-30 |
| K132488 | ZOLL CODE WRITER | ZOLL Medical Corporation | 2014-04-03 |
| K131272 | SIREN EPCR SUITE | Medusa Medical Technologies, Inc. | 2014-01-03 |
| K131919 | ZOLL EPCR IOS | ZOLL Medical Corporation | 2013-12-17 |
| K131816 | SORIN CONNECT DATA MANAGEMENT SYSTEM | Sorin Group Deutschland GmbH | 2013-07-23 |
| K122167 | NEXXIS OR | Barco N.V. | 2013-04-22 |
| K113214 | TLINK DATA MANAGEMENT SYSTEM (DMS) | Terumo Cardiovascular Systems Corp. | 2012-02-07 |
| K111905 | INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-10-04 |
| K112645 | RADIFORCE LARGE MONITOR SYSTEM | Eizo GmbH | 2011-09-22 |
| K103473 | ZOLL RESCUENET EPCR MODEL RESCUENET EPCR | ZOLL Medical Corporation | 2011-05-13 |
| K110085 | VANTAGE VIEW SYSTEM | St Jude Medical | 2011-01-26 |
| K101474 | MD VISION SYSTEM | Perkins Healthcare Technologies | 2010-07-02 |
| K100272 | INTELLIVUE CLINICAL INFORMATION PORTFOLIO | Philips Medical Systems | 2010-04-14 |
| K083321 | CARDIO-VIEW | Curlview Igt, LLC | 2008-11-26 |
| K073372 | ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) | Systemsone | 2007-12-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195278343383 | CARESCAPE CENTRAL STATION | Ge Medical Systems Information Technologies, Inc. | 2026-02-11 |
| 10193489385625 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2023-06-08 |
| B595CSM20500 | Vios Monitoring System Central Station Monitor | MURATA VIOS, INC. | 2020-05-01 |
| B595VCS2050 | Vios Monitoring System Central Server | MURATA VIOS, INC. | 2020-05-01 |
| 10884521795143 | Vital Sync | Covidien LP | 2019-10-05 |
| 10884521795150 | Vital Sync | Covidien LP | 2019-10-05 |
| 00847946021887 | ZOLL Code Writer | Zoll Medical Corporation | 2017-03-17 |
| 00847946021894 | ZOLL Code Writer | Zoll Medical Corporation | 2017-03-17 |
| 00847946021924 | ZOLL ePCR iOS | Zoll Medical Corporation | 2017-03-17 |
| 00840682109604 | CARESCAPE Central Station | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | 2017-02-11 |
| 00840682109666 | CARESCAPE Central Station | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | 2017-02-11 |
| 00884450007532 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-26 |
| 00884450007525 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-26 |
| 00884450007112 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-26 |
| 00884450007105 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-26 |
| 00884450007099 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-26 |
| 00884450006580 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-26 |
| 00884450006962 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450006979 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450006986 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450006993 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450007006 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450007013 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450006955 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450006900 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450007266 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450007358 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00884450007402 | Merit Medical® | Merit Medical Systems, Inc. | 2016-09-24 |
| 00840682109833 | CARESCAPE | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | 2016-06-24 |
| 00840682109826 | CARESCAPE | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | 2016-06-24 |