Videa Dental Assist
VideaHealth, Inc.Videa Dental Assist is an AI-powered software that analyzes intraoral dental X-ray images such as bitewing, periapical, and panoramic radiographs. It assists dental professionals by automatically detecting and localizing suspected dental findings, historical treatments, and normal anatomical features, helping improve diagnostic accuracy and patient management.
Intended Use
Videa Dental Assist is a computer-assisted detection device that analyzes intraoral radiographs to identify and localize multiple dental features including suspected dental findings, historical treatments, and normal anatomy in patients aged 3 years or older.
Technology
Cloud-based AI software accessed via API that processes dental X-ray images to output bounding box detections of features such as caries, restorations, and anatomical landmarks.
Performance
Performance was validated through extensive bench and clinical testing, including a randomized controlled reader study showing statistically significant improvement in diagnostic accuracy for multiple dental findings. Testing included diverse patient ages (3 years and older), multiple radiograph types, and multiple sensor manufacturers, achieving acceptable sensitivity and specificity for all indications.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/8/2023
4 months - 2
FDA Approval
12/15/2023
Other devices from VideaHealth, Inc.
- Videa Perio Assist2023 • 510K
- Videa Caries Assist2022 • 510K
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