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510(k) Data Aggregation
K Number
K120106Device Name
APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM
Manufacturer
Date Cleared
2012-05-07
(115 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
APIXIA INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Apixia Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. Phosphor plates and a scanner are the main components of the device. The device is used to capture x-rays from an external source and produce digital dental radiographs of a patient's mouth. The digital images can be used for analysis, archiving and electronic transmission.
Device Description
Phosphor plates and a scanner are the main components of the device.
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