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510(k) Data Aggregation
(66 days)
The Portable Dental X-ray Device is intended to be used by dental professionals to provide an extraoral X-ray source to produce radiographic images of the teeth using intraoral image receptors for clinical diagnostic purposes.
The Portable Dental X-ray Device is intended to be used by dental professionals to provide an extraoral X-ray source to produce radiographic images of the teeth using intraoral image receptors for clinical diagnostic purposes.
The high voltage generator provides high voltage to both ends of the X-ray tube filament and metal target in the internal X-ray source assembly, a large number of electrons are generated on the cathode filament of the X-ray tube and move at a high speed in the vacuum tube, impacting the metal target to generate the X-ray. The X-ray penetrate the different tissue densities of the body, such as teeth and muscles after passing through the X-ray window and beam tube, the X-ray which carry image information through body tissue, are passed through image receiving devices such as phosphor sheets, film or digital image receivers, to show different densities of human tissue images. The image receptors (necessary accessory for a fully functional intra-oral system) are not part of the subject device.
The product is a high frequency dental X-ray equipment, rated tube voltage is 65kV DC, rate tube current is 2.5 mA, the inverter X-ray control method is adopted, for chemical film and digital sensor diagnostics to obtain high quality dental images, the power supply of GT-1 is 14.4V DC, powered by a rechargeable battery pack.
The USB type-C port is a power-only port, and its data line function is disabled.
The equipment is only for qualified professional technicians and trained or qualified professionals (such as a dentist) in the hospital or clinic to use. The equipment belongs to the radioactive equipment, the operator should operate the equipment according to the users, manual, the equipment shall not be used for other purposes except for medical radiography.
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