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510(k) Data Aggregation
K Number
K151137Device Name
X-VIEW, IMAGEN
Manufacturer
EDLEN IMAGING LLC
Date Cleared
2016-06-07
(405 days)
Product Code
OAS, MUH
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
EDLEN IMAGING LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-VIEW, IMAGEN, a panoramic x-ray imaging system with cephalometric capabilities, is an extraoral source x-ray system intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMI studies and cephalometry. It has the capability of using cone beam volumetric technology techniques to generate dento-maxillofacial 3D images. The device uses a cone shaped x-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed via 3D viewing stations. 2D Images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals.
Device Description
X-VIEW, IMAGEN is a 3-dimensional CBCT system that allows the execution of all commonly used x-rays in both dental and orthodontic fields (excluding intraoral radiographs) and also allows the acquisition of tomographic radiographs, or volumetric 3D. It uses CBCT (Cone Beam Computed Tomography) with a flat panel detector to provide high-definition volumetric images.
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K Number
K150823Device Name
EDLENi Intra-Oral Sensor
Manufacturer
EDLEN IMAGING LLC
Date Cleared
2015-08-26
(152 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
EDLEN IMAGING LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EDLENi sensor is an intra-oral x-ray sensor driven via CMOS technology indicated for the acquirement of intra-oral dental radiographs and intended for dental patients. The EDLENi will be handled via qualified dental and healthcare professionals in order to perform basic dental intra-oral x-ray imaging procedures. The sensors will be used to provide intra-oral radiographic images that ultimately diagnose general dental complications or abnormalities. The EDLENI sensor can be used in combination with positioning devices to facilitate alignment with the x-ray beam, or it may be positioned manually.
Device Description
The EDLENi sensor is an electronic medical device used to acquire intra-oral radiographic images. The sensor can be operated by Radiologists, Dentists, Dental Assistants and other healthcare professionals, who are both trained and competent to take Dental X-ray radiographs. Intra-oral positioning of the sensor is accomplished by the use of dedicated intra-oral positioning devices that facilitate the accurate alignment of the x-ray beam. The sensor may also be aligned with the assistance of the patient. The EDLENi sensor is an indirect light converting digital x-ray detector. A scintillating device composed of Cesium Iodide (CsI) converts incident x-rays into visible light that is optically coupled to a light detection imager based on CMOS technology. The EDLENi allows for automatic detection of such incident x-rays in order to generate data. Software interprets this data into images used for dental applications. The EDLENi sensor supports USB 2.0 direct connectivity to personal computers and or laptops with dedicated electronics and a sensor software driver.
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K Number
K103290Device Name
EDLEN IMAGING - GEMINI DUSB
Manufacturer
EDLEN IMAGING LLC
Date Cleared
2011-09-19
(315 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
EDLEN IMAGING LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Edlen Imaging's Gemini DUSB sensor is a USB-driven digital X-ray sensor that acquires dental intra-oral X-ray images. The sensor will be operated by trained dental and related healthcare professionals to acquire dental intra-oral radiographs.
The Gemini sensor can be used either in combination with special positioning devices, to facilitate alignment with the x-ray beam, or it may also be positioned manually.
Device Description
The Gemini sensor is an indirect light converting digital X-ray detector. Incident X-rays are converted to visible light by a scintillating device, (material) such as Csl (Cesium lodide), the light is coupled optically to a light detection imager which is based on CMOS technology.
The design of the sensor allows for automatic detection of incident X-rays to generate a digital data which when coupled with a software program will display images used for dental intra-oral applications.
The Gemini Digital x-ray sensor supports USB 2.0 Direct connectivity to personal computers and or laptops, hence the name Gemini DUSB.
The Gemini sensors employ built-in dedicated electronics and sensor software driver, to allow connectivity to a variety of software packages. The Gemini sensors are coupled with the currently marketed software, Apteryx XrayVision, K983111.
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