# K012099: Monochrome Perfectly Flat Panel Displays, ME Series

- Pathway: 510(k) (Traditional)
- Applicant: Totoku Electric Co., Ltd.
- Decided: Jul 31, 2001 after 26 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: 1 generation back to K000293 (2000). 1 ancestor in all.
72 later devices descend from it; 4 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000293: Barco MGD 221 2 Megapixel Diagnostic Display, Barco N.V. (2000). Our OCR of the scanned summary read K000923, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “BARCO MGD 221 2 MegaPixel Diagnostic Display”.

## Most influential descendants
- K022109: Eizo, Model FC-2091 (2002), 34 descendants of its own
- K021738: Flat Panel Displays, ME Series & CCL Series (2002), 28 descendants of its own
- K041597: Monochrome LCD Monitor, Model Radiforce G22 (2004), 16 descendants of its own
- K052337: Monochrome LCD Monitor, Model Radiforce G33 (2005), 14 descendants of its own
- K060845: Monochrome LCD Monitor, Radiforce Model GS310 (2006), 13 descendants of its own

## Indications for use
The ME Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.

Source page: https://510kreport.com/device/K012099
Methodology: https://510kreport.com/methodology