# K062905: Nio Fusion 4MP; MDNC 4130

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview
- Decided: Dec 29, 2006 after 93 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 Fusion 4MP is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The Nio Fusion 4MP, containing the display MDNC 4130, the software MediCal QAWeb and the graphic board MXRT 2100, will be marketed as separate device. The MDNC 4130 is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The MDNC 4130, which is part of the Nio Fusion 4MP system, will be marketed separately.

Source page: https://510kreport.com/device/K062905
Methodology: https://510kreport.com/methodology