Nexxis OR— 510(k) K173381
Substantially EquivalentBarco N.V.
FDA 510(k) clearance K173381 for Nexxis OR, Substantially Equivalent on 2018-02-22. Applicant: Barco N.V.. Device class: 2.
Clearance details
- 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
- Special
- Location
- Kortrijk, BE
Recent devices under product code DXJ
view all- K261469 — Nexxis 2; Nexxis OR 2; NMS 2; MNA-240; MNA-4x0 (Where x may be any numeric character).
- K212003 — ESSENZ Patient Monitor
- K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X)
- K201162 — Essence 55SP Large Monitor System
- K173107 — Vios Central Station Monitor Software, Vios Central Server Software
More 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 →
Recalls naming K173381
K-number listed on FDA's recall record- Z-1994-2025 — Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
- Z-2332-2024 — MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
- Z-1854-2022 — Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173381.
Data sourced from openFDA. This site is unofficial and independent of the FDA.