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510(k) Data Aggregation
K Number
K110765Device Name
FXA (TM)
Manufacturer
Date Cleared
2011-11-04
(231 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ACES GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FXATM software is a quantitative imaging software application. It is designed for physicians and clinical professions who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. The FXA™ 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. 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.
Device Description
The FXA™ software is a software tool which was developed to measure static dimensions and to analyze relative motion of implants or bony structures. Basis for the analysis are medical images such as functional radiographs. The FXA™ software was developed with the aim to detect and analyze even small changes with high precision, high reproducibility and low operator variability. For this, patent-pending algorithms were developed and implemented for image-superimposition and the automatic detection of bony structures within selected areas of the image. The software may be installed on workstations with Windows® operating system according to the software requirement specification (SRS, (Attachment B01)).
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