DELTAVIEW MODEL 2.1
RIVERAIN MEDICAL GROUP,LLCDeltaView Model 2.1 is a software tool that processes current and prior chest x-ray images of the same patient to create a difference image highlighting areas of change. This assists radiologists in detecting lung nodules that have changed over time, improving diagnostic accuracy without replacing the original x-ray images.
Intended Use
DeltaView is intended to generate a secondary residual image based on a current and prior chest x-ray image of the same patient, resulting in improved detection of lung nodules.
Technology
DeltaView uses advanced image processing and pattern recognition to register and subtract normalized, bone-suppressed chest x-ray image pairs to create a difference image highlighting areas of change.
Performance
A multi-reader multi-case study demonstrated that DeltaView improves radiologists' diagnostic performance for detecting actionable lung nodules on chest radiographs, showing a statistically significant increase in the area under the localized ROC curve (from 0.477 to 0.536, p=2.9E-05).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/23/2011
6 months - 2
FDA Approval
12/28/2011
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