# K081357: 5MP Grayscale Flat Panel Display, Model, 6GF6201-5C$2# (Where $ = a-Z and # = 0-9)

- Pathway: 510(k) (Traditional)
- Applicant: Eizo GmbH
- Decided: Sep 5, 2008 after 114 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: 7 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)
- K042221: Coronis 5MP Medical Flat Panel Display System, Barco NV Barcoview (2004) Summary page 1.
- K062131: Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BB, Barcoview (2006) Summary page 1.

## Indications for use
The 5MP Grayscale Flat Panel Display is intended to be used in displaying and viewing digital images, including digital mammography, for review, analysis and diagnosis by trained medical practitioners.

Source page: https://510kreport.com/device/K081357
Methodology: https://510kreport.com/methodology