DXJ — Display, Cathode-Ray Tube, Medical Class II
FDA product code DXJ covers "Display, Cathode-Ray Tube, Medical", a Class II medical device regulated under 21 CFR 870.2450. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DXJ
- Device Class
- Class II
- Regulation Number
- 870.2450
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K212003 | livanova deutschland | ESSENZ Patient Monitor | November 10, 2021 |
| K212208 | philips medizin systeme boeblingen | Philips IntelliVue GuardianSoftware (Rev. E.0X) | September 30, 2021 |
| K201162 | shenyang torch-bigtide digital technology co | Essence 55SP Large Monitor System | August 27, 2020 |
| K173107 | vios medical | Vios Central Station Monitor Software, Vios Central Server Software | July 26, 2018 |
| K180534 | philips medizin systeme boeblingen | Philips IntelliVue GuardianSoftware | July 16, 2018 |
| K173381 | barco n.v | Nexxis OR | February 22, 2018 |
| K172969 | shenyang torch-bigtide digital technology co | Essence 55S Large Monitor System | January 26, 2018 |
| K170460 | sorin group deutschland | Sorin Connect | June 8, 2017 |
| K170537 | barco n.v | Nexxis OR, Nexxis | April 21, 2017 |
| K161880 | barco n.v | NIVR58-T kit | March 14, 2017 |
| K161767 | philips medizin systeme boeblingen | Philips IntelliVue GuardianSoftware | January 27, 2017 |
| K162012 | ge healthcare | CARESCAPE Central Station V2 | September 15, 2016 |
| K151366 | philips medical systems | Philips CS770 IntelliSpace Critical Care and Anesthesia | October 30, 2015 |
| K151736 | philips medizin systeme boblingen | Philips IntelliVue GuardianSoftware | October 21, 2015 |
| K133994 | barco n.v | SIVR56-T KIT | December 1, 2014 |
| K133882 | ge medical systems information technologies | CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) | April 30, 2014 |
| K132488 | zoll medical corporation | ZOLL CODE WRITER | April 3, 2014 |
| K131272 | medusa medical technologies | SIREN EPCR SUITE | January 3, 2014 |
| K131919 | zoll medical corporation | ZOLL EPCR IOS | December 17, 2013 |
| K131816 | sorin group deutschland | SORIN CONNECT DATA MANAGEMENT SYSTEM | July 23, 2013 |