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510(k) Data Aggregation
K Number
K230732Device Name
Eagle S/Saevo Slim/D700 Slim
Manufacturer
Alliage S/A Industrias Medica Odontológico.
Date Cleared
2023-04-11
(26 days)
Product Code
MUH, EHD, MQB
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Alliage S/A Industrias Medica Odontológico.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intraoral Dental Digital Imaging Sensor is aimed at the acquisition of intra-oral medical images from teeth, jaw and oral structure, only for exclusive dental use and must be handled by trained and qualified health professionals.
Device Description
This Intraoral Dental Digital Imaging Sensor employs CMOS (Complementary Metal-Oxide-Semiconductor), protective optical fiber and scintillator. There are three names proposed for this device: EAGLE S/ SAEVO SLIM/D700 SLIM. The three models are all identical except for the name. This sensor was developed to obtain a high-quality x-ray image from the human arch and its structures. The acquisition process is made by positioning the sensor inside the mouth, behind the structure you want to perform the exam. The structure must be exposed to an x-ray dose using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital sign and transfers it to a computer through USB connection (Universal Serial Bus). The device performs the acquisition by positioning the sensor inside of the patient's mouth, behind the structure to be examined. The structure should be exposed to a dose of x-rays, using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital signal and then transfers it to a computer via a Universal Serial Bus (USB) connection. The x-ray generator (an integral part of a complete dental x-ray system) is not part of the device.
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