# K063066: Axis-V Monochrome 5 MP Display

- Pathway: 510(k) (Traditional)
- Applicant: National Display Systems
- Decided: Aug 3, 2007 after 301 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: 6 generations back to K001753 (2000). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042221: Coronis 5MP Medical Flat Panel Display System, Barco NV Barcoview (2004) Summary page 1.
- K042755: Monochrome LCD Monitor, Radiforce G51, Eizo Nanao Corporation (2005) Summary page 1.

## Indications for use
The AXIS-V 5MP Radiological Monochrome Medical Display is intended to be used to display and view digital images, including digital mammography, for review and analysis by trained medical practitioners.

Source page: https://510kreport.com/device/K063066
Methodology: https://510kreport.com/methodology