Dental Cone Beam Computed Tomography System
Yofo Medical Technology Co., Ltd.The Dental Cone Beam Computed Tomography System by Yofo Medical Technology Co., Ltd. is designed for dental and maxillofacial imaging using cone beam CT technology. It produces detailed 3D images of patients' oral and maxillofacial regions to assist clinicians in diagnosis and treatment planning, improving patient care in dental and maxillofacial medicine.
Intended Use
The Dental Cone Beam Computed Tomography System is intended to be used by medical institutions for X-ray image diagnosis on oral and maxillofacial areas through X-ray Cone Beam Computed Tomography (CBCT).
Technology
This CBCT system uses two configurations with two or one X-ray tube assemblies, flat panel amorphous silicon detector, and includes a workstation software for 3D reconstruction, multi-slice views, and accurate anatomical measurements. The device has an electric powered seat for positioning, touch screen controls, safety interlocks and exposure switches for real-time scanning control.
Performance
Performance testing included software verification and validation, electrical safety and electromagnetic compatibility testing, biocompatibility evaluation, bench testing for image quality parameters, and clinical review of sample images by an experienced radiologist confirming acceptable image quality for adult and pediatric patients.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/25/2024
5 months - 2
FDA Approval
4/17/2025
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