DXJ · Display, Cathode-Ray Tube, Medical
Cardiovascular · 21 CFR 870.2450 · Class 2
Overview
| Product Code | DXJ |
|---|---|
| Device Name | Display, Cathode-Ray Tube, Medical |
| Regulation | 21 CFR 870.2450 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 78)
Showing 20 most recent of 78 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K212003 | ESSENZ Patient Monitor | Livanova Deutschland, GmbH | Nov 10, 2021 | SESE |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Philips Medizin Systeme Boeblingen GmbH | Sep 30, 2021 | SESE |
| K201162 | Essence 55SP Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | Aug 27, 2020 | SESE |
| K173107 | Vios Central Station Monitor Software, Vios Central Server Software | Vios Medical, Inc. | Jul 26, 2018 | SESE |
| K180534 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | Jul 16, 2018 | SESE |
| K173381 | Nexxis OR | Barco N.V. | Feb 22, 2018 | SESE |
| K172969 | Essence 55S Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | Jan 26, 2018 | SESE |
| K170460 | Sorin Connect | Sorin Group Deutschland GmbH | Jun 8, 2017 | SESE |
| K170537 | Nexxis OR, Nexxis | Barco N.V. | Apr 21, 2017 | SESE |
| K161880 | NIVR58-T kit | Barco N.V. | Mar 14, 2017 | SESE |
| K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | Jan 27, 2017 | SESE |
| K162012 | CARESCAPE Central Station V2 | GE Healthcare | Sep 15, 2016 | SESE |
| K151366 | Philips CS770 IntelliSpace Critical Care and Anesthesia | Philips Medical Systems | Oct 30, 2015 | SESE |
| K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | Oct 21, 2015 | SESE |
| K133994 | SIVR56-T KIT | Barco N.V. | Dec 1, 2014 | SESE |
| K133882 | CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) | Ge Medical Systems Information Technologies, Inc. | Apr 30, 2014 | SESE |
| K132488 | ZOLL CODE WRITER | ZOLL Medical Corporation | Apr 3, 2014 | SESE |
| K131272 | SIREN EPCR SUITE | Medusa Medical Technologies, Inc. | Jan 3, 2014 | SESE |
| K131919 | ZOLL EPCR IOS | ZOLL Medical Corporation | Dec 17, 2013 | SESE |
| K131816 | SORIN CONNECT DATA MANAGEMENT SYSTEM | Sorin Group Deutschland GmbH | Jul 23, 2013 | SESE |
Top Applicants
- Hewlett-Packard Co. — 7 clearances
- Barco N.V. — 5 clearances
- Litton Medical Electronics — 5 clearances
- Vidco, Inc. — 5 clearances
- Honeywell, Inc. — 4 clearances
