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510(k) Data Aggregation
K Number
K181636Device Name
Aurora
Manufacturer
Date Cleared
2018-07-20
(29 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Sodium Systems, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Aurora is an intra-oral sensor used by dental professionals for the purpose of acquiring x-ray images to be used for the diagnosis of diseases of the mouth and for evaluating general dental health.
Device Description
Aurora is an intraoral digital x-ray system used to acquire digital x-ray images when used with an external x-ray source. The sensor is composed of a scintillation plate that converts incident x-ray light into visible light, which is coupled to a CMOS detector via a fiber optic plate (FOP) collimator. It connects to a PC via a 2-meter cable with USB 2.0 interface. A trained dental professional (e.g. Dentist, Dental Assistant, etc.) will operate the sensor by aligning the device inside the mouth using a positioning device, such as ring and bar holder, and then using an external x-ray source (i.e. dental x-ray tube head) to expose the sensor to radiation with the oral tissue of interest between. A software package will control the acquisition of the x-ray image from the sensor itself and will interpret the data to create an image on a computer screen for the dentist to use for diagnosis. Neither the software package nor the x-ray sensor controls the x-ray generating source in any fashion. The software package used by Sodium Dental is Xray Vision® from Apteryx, Inc (K983111). The Xray Vision® software is a network-based image acquisition and management software used to acquire x-ray/camera images and store them in a patient database.
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