Nexxis or
FDA 510(k) K122167 · Barco N.V.
510(k) numberK122167
Submission
- Device name
- Nexxis or
- Applicant
- Barco N.V.
Kortrijk, BE - Received
- July 23, 2012
- Decision date
- April 22, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
Other 510(k)s with product code DXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212003 | ESSENZ Patient MonitorDXJ · Special | Livanova Deutschland, GmbH | 11/10/2021SE |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 09/30/2021SE |
| K201162 | Essence 55SP Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 08/27/2020SE |
| K173107 | Vios Central Station Monitor Software, Vios Central Server SoftwareDXJ · Traditional | Vios Medical, Inc. | 07/26/2018SE |
| K180534 | Philips IntelliVue GuardianSoftwareDXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 07/16/2018SE |
| K173381 | Nexxis ORDXJ · Special | Barco N.V. | 02/22/2018SE |
| K172969 | Essence 55S Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 01/26/2018SE |
| K170460 | Sorin ConnectDXJ · Special | Sorin Group Deutschland GmbH | 06/08/2017SE |
| K170537 | Nexxis OR, NexxisDXJ · Special | Barco N.V. | 04/21/2017SE |
| K161880 | NIVR58-T kitDXJ · Special | Barco N.V. | 03/14/2017SE |
More from Barco N.V.
| 510(k) | Device | Decision |
|---|---|---|
| K243307 | LCD Monitor (MDEC-2523)GCJ · Traditional | 12/13/2024SE |
| K242008 | Coronis OneLookPGY · Special | 08/02/2024SE |
| K233693 | Nio Color 8MP (MDNC-8132)PGY · Special | 12/11/2023SE |
| K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)PGY · Special | 03/21/2023SE |
| K213957 | Demetra Dermatoscope BDEM-01PSN · Special | 03/11/2022SE |
| K203364 | MDPC-8127PSY · Traditional | 04/15/2021SE |
| K201408 | Demetra Analytics ToolkitPSN · Traditional | 02/18/2021SE |
| K203106 | Nio Fusion 12MP (MDNC-12130)PGY · Special | 11/10/2020SE |
| K192829 | Demetra BDEM-01 DermatoscopePSN · Traditional | 12/13/2019SE |
| K191845 | Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools…PGY · Traditional | 09/06/2019SE |
Questions and answers
When was Nexxis or cleared by the FDA?
Nexxis or (K122167) received a 510(k) decision of Substantially Equivalent on April 22, 2013, 273 days after the submission was received.
What is the product code of K122167?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.