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510(k) Data Aggregation
K Number
K111103Device Name
DIGITAL X-RAY IMAGING SYSTEM
Manufacturer
RF CO., LTD
Date Cleared
2012-01-05
(260 days)
Product Code
MUH, EHD, MQB
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
RF CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NAOMI-DPX D100 is indicated for use in acquiring Panoramic radiographic images at the dento-maxillofacial region. The image generated is displayed on a computer monitor. It is intended to replace radiographic film/screen system in dental diagnostic procedures
Device Description
The NAOMI-DPX-D100 provided digital image capture for conventional film/screen systems. It is intended to replace the radiographic film/screen systems.
The x-ray photons incident to the NAOMI-DPX-D100 are detected and converted into the light photons at the scintillator. The light photons are detected and converted into the electrical signal at the CCD. NAOMI-DPX software captures and displays the image.
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