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510(k) Data Aggregation
K Number
K111312Device Name
SANTEVIEW
Manufacturer
Date Cleared
2011-07-13
(64 days)
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
SEHYUN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SanteView-3001C provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
Device Description
The SanteView-3001C is a solid state x-ray imager which has 440x440mm imaging area. The SanteView-3001C intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors.
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