# K051201: E1 Medical Flat Panel Display System and MFGD 1218 Medical Flat Panel Display

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview
- Decided: May 26, 2005 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: 4 generations back to K001753 (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)
- K042660: Nio 2MP Medical Flat Panel Display System, Barco NV Barcoview (2004) Summary page 5.

## Indications for use
The E 1 Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The MFGD 1218 Medical Flat Panel Display is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K051201
Methodology: https://510kreport.com/methodology