Dental Cone-beam Computed Tomography (FinScan F350)
Changzhou Finno Medical Technology Co., Ltd.The Dental Cone-beam Computed Tomography (FinScan F350) is an imaging system designed for dental and maxillofacial diagnostic support. It uses cone-beam CT technology along with panoramic and cephalometric X-ray imaging to produce detailed images of the dento-maxillofacial and TMJ structures, aiding dentists and health professionals in diagnosis, including assessment of growth and maturity for orthodontic treatment.
Intended Use
FinScan F350 is CBCT, panoramic and cephalometric X-ray imaging system for radiographic examination of the dento-maxillofacial and TMJ structures for diagnostic support in adult and pediatric patients. Cephalometric image includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. Device operated by dentists or qualified health professionals.
Technology
The device includes a column, rotating unit, tube head assembly, CBCT/panoramic detector, cephalometric detector, workstation and image processing software. It uses cone-beam computed tomography technology with TFT and CMOS detectors and operates with continuous/intermittent loading. It produces 3D, panoramic, and cephalometric images compatible with DICOM 3.0 format.
Performance
Performance testing included biocompatibility (cytotoxicity, irritation, sensitization), electrical safety and EMC compliance with IEC and FDA recognized standards, software verification and validation, bench testing following FDA guidance, and clinical evaluation by US board certified dentists confirming acceptable image quality for clinical use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/17/2024
3 months - 2
FDA Approval
1/9/2025
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