Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2450](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2450) → DXJ — Display, Cathode-Ray Tube, Medical # DXJ · Display, Cathode-Ray Tube, Medical _Cardiovascular · 21 CFR 870.2450 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ ## Overview - **Product Code:** DXJ - **Device Name:** Display, Cathode-Ray Tube, Medical - **Regulation:** [21 CFR 870.2450](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2450) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K212003.md) | ESSENZ Patient Monitor | Livanova Deutschland, GmbH | Nov 10, 2021 | SESE | | [K212208](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K212208.md) | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Philips Medizin Systeme Boeblingen GmbH | Sep 30, 2021 | SESE | | [K201162](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K201162.md) | Essence 55SP Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | Aug 27, 2020 | SESE | | [K173107](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K173107.md) | Vios Central Station Monitor Software, Vios Central Server Software | Vios Medical, Inc. | Jul 26, 2018 | SESE | | [K180534](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K180534.md) | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | Jul 16, 2018 | SESE | | [K173381](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K173381.md) | Nexxis OR | Barco N.V. | Feb 22, 2018 | SESE | | [K172969](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K172969.md) | Essence 55S Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | Jan 26, 2018 | SESE | | [K170460](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K170460.md) | Sorin Connect | Sorin Group Deutschland GmbH | Jun 8, 2017 | SESE | | [K170537](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K170537.md) | Nexxis OR, Nexxis | Barco N.V. | Apr 21, 2017 | SESE | | [K161880](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K161880.md) | NIVR58-T kit | Barco N.V. | Mar 14, 2017 | SESE | | [K161767](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K161767.md) | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | Jan 27, 2017 | SESE | | [K162012](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K162012.md) | CARESCAPE Central Station V2 | GE Healthcare | Sep 15, 2016 | SESE | | [K151366](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K151366.md) | Philips CS770 IntelliSpace Critical Care and Anesthesia | Philips Medical Systems | Oct 30, 2015 | SESE | | [K151736](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K151736.md) | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | Oct 21, 2015 | SESE | | [K133994](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K133994.md) | SIVR56-T KIT | Barco N.V. | Dec 1, 2014 | SESE | | [K133882](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K133882.md) | CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) | Ge Medical Systems Information Technologies, Inc. | Apr 30, 2014 | SESE | | [K132488](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K132488.md) | ZOLL CODE WRITER | ZOLL Medical Corporation | Apr 3, 2014 | SESE | | [K131272](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K131272.md) | SIREN EPCR SUITE | Medusa Medical Technologies, Inc. | Jan 3, 2014 | SESE | | [K131919](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K131919.md) | ZOLL EPCR IOS | ZOLL Medical Corporation | Dec 17, 2013 | SESE | | [K131816](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ/K131816.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com