# K042353: Axis I (1MP), II (2MP), Iii (3MP), and V (5MP) Monochrome Displays

- Pathway: 510(k) (Traditional)
- Applicant: National Display Systems
- Decided: Nov 24, 2004 after 86 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040310: Nova Family of Medical Radiology Displays, National Display Systems (2004) Summary page 1.
- K023340: Coronis 1MP Medical Flat Panel Display System, Barco N.V. (2002) Summary page 1.
- K023322: Coronis 2MP Medical Flat Panel Display System, Barco N.V. (2002) Summary page 1.
- K032202: Dome CX Digital Flat-Panel Display System, Models C2 and C5I, Planar Systems, Inc. (2003) Summary page 1.
- K013922: Coronis 3MP Medicl Flat Panel Display System, Barco N.V. (2002) Summary page 1.
- K032638: Dome CX Digital Flat-Panel Display System Model, C3 Color and C3 Gray, Planar Systems, Inc. (2003) Summary page 1.
- K023341: Cornis 5MP Medical Flat Panel Display System, Barco N.V. (2002) Summary page 1.

## Indications for use
The AXIS Radiology Monochrome Medical Displays are intended to be used to display and view digital images for review and analysis by trained medical practitioners. The AXIS 5MP display is currently not cleared in the U.S. for use with Full Field Digital Mammography (FFDM). The AXIS IMP, 2MP and 3MP displays are not intended for use with FFDM.

Source page: https://510kreport.com/device/K042353
Methodology: https://510kreport.com/methodology