# K170837: Nio Color 3MP (MDNC-3421)

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: Apr 5, 2017 after 15 days
- Product code: PGY (Display, Diagnostic Radiology)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K131295 (2013). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131295: Nio Color 3MP Led, Barco N.V. (2013) Summary page 4.

## Most influential descendants
- K230520: Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) (2023), 1 descendant of its own
- K233693: Nio Color 8MP (MDNC-8132) (2023), 0 descendants of its own
- K191705: OptikView GUP2103CMI (2020), 0 descendants of its own
- K171812: Nio Color 2MP (MDNC-2123) (2017), 0 descendants of its own

## Recalls of this device
- Jan 22, 2021 · Class II · Z-1172-2021: A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.

## Indications for use
The Nio Color 3MP LED Medical Flat Panel Display System is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The display may be used in dental applications.

Source page: https://510kreport.com/device/K170837
Methodology: https://510kreport.com/methodology