# K070726: Nio Color 3MP and MDNC 3120

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview, Medical Imaging Systems
- Decided: May 2, 2007 after 48 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: 5 generations back to K001753 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052958: Color Nio 2MP, E-2320 C, Barcoview (2005) Summary page 1.

## Indications for use
The Nio Color 3MP 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 Nio Color 3MP, containing the display MDNC 3120, the software MediCal QAWeb Agent and a graphic board, will be marketed as separate device. The MDNC 3120 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 MDNC 3120, which is part of the Nio Color 3MP system, will be marketed separately.

Source page: https://510kreport.com/device/K070726
Methodology: https://510kreport.com/methodology