Nexxis 2; Nexxis OR 2; NMS 2; MNA-240; MNA-4x0 (Where x may be any numeric character).— 510(k) K261469
Substantially EquivalentBarco N.V.
FDA 510(k) clearance K261469 for Nexxis 2; Nexxis OR 2; NMS 2; MNA-240; MNA-4x0 (Where x may be any numeric character)., Substantially Equivalent on 2026-09-30. Applicant: Barco N.V.. Device class: 2.
Summary
Barco N.V. cleared a group of products in one submission: Nexxis 2, Nexxis OR 2, NMS 2, MNA-240, and an MNA-4x0 series, where the record says x can be any digit. The product code is DXJ, medical cathode-ray tube displays. The code name still says cathode-ray tube; the record doesn't describe the display or video technology in these products.
Class II under 21 CFR 870.2450. The record lists Cardiovascular as the advisory panel and General and Plastic Surgery as the review panel. It was a Traditional 510(k).
Barco filed from Kortrijk, Belgium. Review took 149 days (May 4 to September 30, 2026).
Clearance details
- Device name as filed
- Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character).
- Applicant
- Barco N.V.
- Product code
- Product code DXJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kortrijk, BE
Recent devices under product code DXJ
view allMore clearances from Barco N.V.
view allAdverse events under product code DXJ
product code DXJ- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.