Search Results
Found 1 results
510(k) Data Aggregation
K Number
K223816Device Name
Dental CT Scanner AXR
Manufacturer
Date Cleared
2023-04-07
(108 days)
Product Code
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Alliage S/A Industrias Medico Odontológica.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DENTAL CT SCANNER AXR is designed to obtain 2D and 3D radiological images of the oral anatomy, including teeth, maxillofacial areas, oral structures, carpal images and head-neck bone regions. This system is exclusively for dental use and should be handled only by qualified health professionals.
Device Description
The Dental CT Scanner AXR is a complete 4-in-1 dental imaging system capable of generating panoramic, cephalometric and tomographic images using cone beam computerized tomography technique (Cone Beam). The AXR90 has a maximum kVp of 90 while the AXR120 has a maximum kVp of 120. The digital acquisition process utilizes an X-ray sensor and automatic image processing that allow you to increase the speed of diagnosis and improve the workflow of your clinic.
Ask a Question
Ask a specific question about this device
Page 1 of 1