# K110765: FXA (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Aces GmbH
- Decided: Nov 4, 2011 after 231 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 K022585 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022585: Kimax Qma, Medical Metrics, Inc. (2002) Summary page 2.

## Indications for use
The FXATM software is a quantitative imaging software application. It is designed for physicians and clinical professionals who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. The FXATM software permits users to review static and dynamic digital images acquired from a variety of radiographic sources for the purpose of facilitating a quantitative assessment of relative motion and static measurement parameters. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a report containing graphics, charts, text and statistical data.

Source page: https://510kreport.com/device/K110765
Methodology: https://510kreport.com/methodology