# K110108: Modalixx

- Pathway: 510(k) (Traditional)
- Applicant: Ampronix, Inc.
- Decided: Mar 16, 2011 after 61 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 K000293 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021738: Flat Panel Displays, ME Series & CCL Series, Totoku Electric Co., Ltd. (2002) Summary page 2.

## Indications for use
The MODALIXX G2O2MP display is intended to be used in displaying and viewing digital images for review by trained medical practitioners before the digital images are sent to other diagnostic displays. Modalixx G2O2MP is not meant to be used for mammography applications.

Source page: https://510kreport.com/device/K110108
Methodology: https://510kreport.com/methodology