# K040443: Dome CX Digital Flat-Panel Display System, Model C5I

- Pathway: 510(k) (Traditional)
- Applicant: Dome Imaging Systems, Inc.
- Decided: Jun 16, 2004 after 117 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). 5 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032202: Dome CX Digital Flat-Panel Display System, Models C2 and C5I, Planar Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K042221: Coronis 5MP Medical Flat Panel Display System (2004), 6 descendants of its own
- K062131: Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BB (2006), 2 descendants of its own
- K062621: Nio 5MP-21 and MDNG-5121 CB (2007), 1 descendant of its own
- K160347: Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 (2016), 0 descendants of its own
- K132610: 5MP Grayscale LCD Display (2013), 0 descendants of its own

## Indications for use
The DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, Model C5i is intended to be used in displaying and viewing radiographs of the breast for review and analysis by trained medical practitioners.

Source page: https://510kreport.com/device/K040443
Methodology: https://510kreport.com/methodology