SMARTDent
RAY Co., Ltd.SMARTDent is a software solution developed by RAY Co., Ltd. that helps dental professionals manage and analyze various types of dental imaging, including CT, panoramic, cephalometric, and intraoral X-rays. It streamlines image management and provides tools that support diagnosis, thereby assisting clinicians in dental care.
Intended Use
SMARTDent is intended for use as a software solution for managing dental diagnostic images and providing tools to support diagnosis.
Technology
SMARTDent manages various types of dental images acquired via X-ray imaging equipment and performs various image analyses according to diagnostic purposes.
Performance
Software, hardware, and integration verification and validation testing were performed per FDA Guidance, including mitigation validations for device hazards. All testing showed SMARTDent to be substantially equivalent to the predicate device. Clinical testing was not required nor performed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/11/2025
1 month - 2
FDA Approval
5/21/2025
Other devices from RAY Co., Ltd.
- RCT6002025 • 510K
- RAYDENT SW2024 • 510K
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