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HepaFat-Scan® Product Specifications
Sensitivity and Specificity
The HepaFat–Scan analysis has high sensitivity and specificity for predicting steatosis grade from liver biopsy.
| Steatosis Grades | Grade ≥ 1 | Grade ≥ 2 | Grade = 3 |
|---|---|---|---|
| Sensitivity (95% conf interval) | 0.97 (0.84-0.99) | 0.86 (0.66-0.97) | 0.92 (0.66-0.99) |
| Specificity (95% conf interval) | 0.88 (0.64-0.99) | 0.89 (0.71-0.98) | 0.86 (0.70-0.95) |
Vos, et al. (2020) GastroHep, 2: 171
Technical Specifications
Technology
3 point Dixon with a correction for iron contribution
HepaFat-Scan calibration and validation
Calibrated using 59 liver biopsies and validated using another 50 liver biopsies. Also validated in Children using 50 liver biopsies.
Evaluation
Volumetric liver fat fraction (VLFF)
Longitudinal monitoring capability
Yes
Patient age groups
All excluding neonates
Results generated
Within 24 hours (1 working day)
Data acquisition time
2 minutes
Breathhold requirements
Yes
Contrast agents
None
Slices
3
Data transfer and report delivery system
Via HIPPA &
GDPR compliant secure portal system
GDPR compliant secure portal system Scanner compatibility
Compatible on 1.5T & 3T machines, including 
,
, General Electrics and 
others.
,, General Electrics and others. Software requirements
None
Hardware requirements
None specific as long as the required imaging protocol can be achieved
MRI scanner validation
With saline bag Quality assured certification
ISO 13485:2016
Clearances
FDA 510(k) cleared • 
• 
• ARTG included