(135 days)
The HealthFLD device is an image processing software that provides quantitative and qualitative analysis of the liver from CT images to support clinicians in the evaluation and assessment of Fatty Liver. The HealthFLD software provides measurements of liver attenuation (mean HU in a region of interest). HealthFLD is indicated for use in non-contrast and contrast CT scans, with any clinical indication, for patients aged 18 up to 75. CTs must include a significant part of the liver. The HealthFLD device is not intended to provide a diagnosis or risk assessment of fatty liver disease.
The HealthFLD device is an image processing software that provides quantitative and qualitative analysis of the liver from CT images to support clinicians in the evaluation and assessment of Fatty Liver.
The HealthFLD software provides measurements of liver attenuation (mean HU in a region of interest) for any compatible CT scan that includes a significant part of the liver
The Liver measurement display threshold is
Here's a breakdown of the acceptance criteria and the study proving the HealthFLD device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Binary Classification Agreement | Agreement with ground truth liver score binary classification of |
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.