# K052958: Color Nio 2MP, E-2320 C

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview
- Decided: Nov 16, 2005 after 26 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001753 (2000). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042660: Nio 2MP Medical Flat Panel Display System, Barco NV Barcoview (2004) Summary page 1.
- K040158: MFCD 2320, Barco N.V. (2004) Summary page 3.

## Most influential descendants
- K070726: Nio Color 3MP and MDNC 3120 (2007), 0 descendants of its own
- K062905: Nio Fusion 4MP; MDNC 4130 (2006), 0 descendants of its own

## Indications for use
The Color Nio 2MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The E-2320 C is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K052958
Methodology: https://510kreport.com/methodology