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510(k) Data Aggregation
K Number
K233925Device Name
Relu Creator
Manufacturer
Relu BV
Date Cleared
2024-06-13
(183 days)
Product Code
QIH
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Relu BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Relu Creator is a software program for the management, transfer, and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.
Device Description
The Relu Creator is a software that is part of the digital workflow of dental specialists in preoperative planning. The main purpose is the 3D modeling of the patient anatomy, which is technically called image segmentation and multimodel registration. Based on the model, simulations for preoperative and pretreatment planning can be carried out for dental applications. The 3D modeling (segmentation + registration) is performed on medical images like CBCT, IOS and FS. The preoperative/pretreatment software can be applied in various dental disciplines such as orthodontics, implantology, and maxillofacial surgery.
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