# K060136: Planar Dome EX Series Digital Flat-Panel Display System, Model E4C Color

- Pathway: 510(k) (Traditional)
- Applicant: Planar Systems, Inc.
- Decided: Jan 31, 2006 after 12 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: 3 generations back to K001753 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013922: Coronis 3MP Medicl Flat Panel Display System, Barco N.V. (2002) Summary page 2.
- K032638: Dome CX Digital Flat-Panel Display System Model, C3 Color and C3 Gray, Planar Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K120709: The Dome GX4MP Color Nonitor (2012), 0 descendants of its own

## Indications for use
The Planar DOME DIGITAL FLAT-PANEL DISPLAY SYSTEM, Model E4c is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners. This device must not be used in primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K060136
Methodology: https://510kreport.com/methodology