Search Results
Found 1 results
510(k) Data Aggregation
K Number
K122606Device Name
PHT-6500; PHT-60CFO; PAX-I3D
Manufacturer
MTECH GROUP
Date Cleared
2012-11-20
(85 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
MTECH GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PHT-6500 (PHT-60CFO) is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry . The device is operated and used by physicians, dentists, and x-ray technicians.
Device Description
PHT-6500 (PHT-60CFO), a dental radiographic imaging system, consists of three different image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-6500 (PHT-60CFO) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography.
The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector.
Ask a Question
Page 1 of 1