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510(k) Data Aggregation
K Number
K161131Device Name
FONA Pan/Ceph
Manufacturer
Date Cleared
2016-11-03
(196 days)
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
FONA SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FONA Pan/Ceph device, comprising models FONA XPan DG Plus, FONA ART Plus, and FONA ART Plus C, is an extraoral source dental X-ray system intended to perform panoramic or cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry, as well as carpal images.
Device Description
The FONA Pan/Ceph device is an X-ray equipment designed for:
- Dental panoramic radiography
- Cephalometry, when completed with lateral Ceph arm. .
The FONA Pan/Ceph device comprises four models:
- FONA XPan DG and FONA XPan DG Plus, with CCD type of image receptor with CsI scintillator
- FONA ART Plus, FONA ART Plus C, with CMOS type of image receptor with Cd(Zn)Te scintillator. ●
All the models allow for panoramic projections and two of them are extended with cephalometric functionality:
- . The models FONA XPan DG and FONA ART Plus feature panoramic projections only (type Pan Solo) and are thus equipped with a fixed image receptor mounted on the rotating arm.
- The models FONA XPan DG Plus and FONA ART Plus C feature panoramic and cephalometric projections ● (type Pan Ceph) and are equipped with a detachable image receptor to be placed on the rotating arm, for the panoramic modality, or on the cephalometric arm, for the cephalometric modality.
The control panel on the unit contains keys and signaling lights for a complete control of the operation and for the setting of the desired technique factors.
Class I LASER aiming lights support positioning of patient's head. which is stabilized through the use of bite blocks, chin rest, and, in case, temple supports.
The user controls the exposure using a manual hand-switch, implementing the dead man functionality.
An Ethernet connection cable allows the FONA Pan/Ceph device to interface with a computer for image acquisition, processing and storage.
The user may thus view and store the radiographic images using a software installed on a side computer with peripheral components such as a mouse, keyboard, and monitor. The software takes care of acquisition, processing, displaying, and archiving the image data.
A TWAIN interface is also available for interfacing to other existing programs with processing and storage capabilities, according to the user's needs.
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