# K061018: Planar Dome EX Line Model Dome E2C

- Pathway: 510(k) (Traditional)
- Applicant: Planar Systems, Inc.
- Decided: Apr 28, 2006 after 15 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 K000294 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052352: Color Coronis 2MP-21 and MFCD 2321, Barcoview (2005) Summary page 1.

## Indications for use
The Planar Dome® EX line Model Dome® E2c is intended to be used in displaying and viewing digital medical images for review, analysis, and diagnosis by trained medical practitioners. This device must not be used in primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K061018
Methodology: https://510kreport.com/methodology