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510(k) Data Aggregation
K Number
K090431Device Name
DEXIS SOFTWARE
Manufacturer
DEXIS LLC
Date Cleared
2009-06-22
(123 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DEXIS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital images from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.
Device Description
The DEXIS Software is a software program for general dental and maxillo-facial diagnostic imaging. It controls capture, display, enhancement and saving of x-ray digital images from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intraoral or extraoral dental cameras. DEXIS Software allows the following functionality:
- Control scanning and intake of x-ray images from imaging plates with the DenOptix scanner.
- Control the direct capture of x-ray images from the intraoral sensor Visualix / GX-S. KaVo Dig eXam, Orthoralix DPI & DDE series systems.
- View and capture color images from certain cameras, such as dental camera, via a suitable video capture card.
- Export and import digital images (such as those obtained by scanning a film) in several standard file formats.
- Process images with dental specific tools, to enhance their diagnostic value.
- Analyze and manipulate images in order to gather additional diagnostic information which may not be immediately apparent on initial visual inspection.
- Create a database of patients and easily store images in patient folders.
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K Number
K090458Device Name
DEXIS SENSOR
Manufacturer
DEXIS LLC
Date Cleared
2009-05-28
(94 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
DEXIS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEXIS sensor is a USB-driven digital sensor which is intended to acquire dental intra-oral radiography images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
Device Description
The DEXIS sensor is an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology.
The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra-oral applications.
The DEXIS sensor supports USB 2.0 and USB 1.1 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.
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