# K161880: NIVR58-T kit

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: Mar 14, 2017 after 249 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K133994 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133994: SIVR56-T Kit, Barco N.V. (2014) Summary page 5.

## Indications for use
The kit is intended to be used by healthcare professionals to integrate the video from various commercially available instruments commonly used in a medical procedure into a single video display.

Source page: https://510kreport.com/device/K161880
Methodology: https://510kreport.com/methodology