# K173381: Nexxis OR

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: Feb 22, 2018 after 115 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K122167 (2013). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170537: Nexxis OR, Nexxis, Barco N.V. (2017) Summary page 4.
- K122167: Nexxis or, Barco N.V. (2013) Summary page 4.

## Most influential descendants
- K261469: Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character). (2026), 0 descendants of its own

## Recalls of this device
- May 9, 2025 · Class II · Z-1994-2025: Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video and/or control s
- Apr 24, 2024 · Class II · Z-2332-2024: We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDMI or MNA-4x0 ENC HDMI. In some instances
- Jul 27, 2022 · Class II · Z-1854-2022: installation issues

## Indications for use
The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and medical images from various commercially available instruments that are commonly used in a medical procedure laboratory or operating room. The Barco Nexxis OR system is also designed for transfer, selection and distribution of human interface signals and control signals of non-medical room equipment, The Barco Nexxis OR system allows control and selection of these signals from a central point. The Barco Nexxis OR system is not intended to be used for remote or robotically assisted surgery, The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or other devices that use strong magnetic fields.

Source page: https://510kreport.com/device/K173381
Methodology: https://510kreport.com/methodology