Relu Creator is a software program used by dental specialists to manage and analyze dental and craniomaxillofacial medical images. It helps with 3D modeling of patient anatomy through image segmentation and registration, supporting preoperative planning and treatment in dental disciplines like orthodontics and implantology. The software enhances and displays images from multiple sources and stores them for easy access, assisting clinicians in planning dental treatments more effectively.
Intended Use
Relu Creator is a software program for the management, transfer, and analysis of dental and craniomaxillofacial image information, used to provide design input for dental solutions supporting diagnostic process and treatment planning.
Technology
Relu Creator performs 3D modeling via automatic segmentation and multimodal registration of medical images like CBCT, IOS, and FS. It outputs in formats used in dental planning. It is implemented in web and local app forms and does not perform image acquisition itself.
Performance
Verification and validation testing demonstrated that Relu Creator is safe and effective for its intended use, showing substantial equivalence to the predicate device DTX Studio 3.0. There are no substantial differences in performance, technological features, or intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/13/2023
6 months - 2
FDA Approval
6/13/2024
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