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K Number
K242805Device Name
Dental Cone-beam Computed Tomography (FinScan F350)
Manufacturer
Changzhou Finno Medical Technology Co., Ltd.
Date Cleared
2025-01-09
(114 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Changzhou Finno Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FinScan F350 is CBCT, panoramic and cephalometric x-ray imaging system. The device is intended to radiographic examination of the dento-maxillofacial and TMJ structure for diagnostic support for adult and pediatric patients. Cephalometric image also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment.
The device is to be operated and used by dentists or other legally qualified health care professionals.
Device Description
Dental Cone-beam Computed Tomography (model: FinScan F350) uses cone-beam computed tomography (CBCT) technology through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of the dento-maxillofacial and TMJ structure to provides diagnostic details for dental clinics and dental hospitals.
This product mainly consists of column, rotating unit, tube head assembly, CBCT/panoramic detector, cephalometric detector, the workstation and image processing software.
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