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510(k) Data Aggregation
K Number
K133206Device Name
Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM
Manufacturer
Date Cleared
2014-05-13
(208 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
ZUMA DENTAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Z-Ray digital radiography system was designed for the sole purpose of capturing radiographic images of teeth and the surrounding structures limited to the oral cavity. This device should be used under the direction of a licensed Dentist when it is deemed necessary to perform a radiographic series of a patient for diagnostic purposes.
Device Description
The Zuma Dental Z-ray x-ray image sensor is a fully integrated CMOS photodiode array specifically designed for dental radiography. The sensor is available in two image sizes that correspond to a #2 size and a #1 size dental film. Each consists of a matrix of silicon photodiodes on 22.5 um centers. An integrated scintillator screen converts x-ray photons to visible light sensed by the silicon photodiodes. A rugged thermoplastic enclosure, with rounded corners for patient comfort, protects the sensor from everyday handling and cleaning. The CMOS sensor connects directly to a USB/PC connection without the need for an intermediate electrical interface. Zuma Z-Ray works with standard dental extra-oral x-ray sources without connection to the x-ray source. Zuma Z-Ray captures an image automatically upon sensing the external x-ray source and after completion of the x-ray procedure, transfers the image to an imaging software program on the PC for diagnostic evaluation.
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