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510(k) Data Aggregation
K Number
K113497Device Name
HYPERION
Manufacturer
Date Cleared
2012-01-17
(53 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
CEFLA DENTAL GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The hyperion is a digital panoramic and cephalometric extra-oral X-ray system, indicated for use in:
- producing panoramic X-ray images of the maxillofacial area, for (i) diagnostic examination of dentition (teeth), jaws and oral structures; and
- · producing radiographs of the jaws and parts of the skull, for the (ii) purpose of cephalometric examination if equipped with CEPH arm.
Device Description
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K Number
K100960Device Name
WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS
Manufacturer
Date Cleared
2010-10-21
(197 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
CEFLA DENTAL GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The WDS X-POD and ZEN-X Digital X-Ray Sensors are intended to capture intraoral digital images when exposed to X-Rays. The process is automatic and transmits the digital image to a personal computer by wireless Bluetooth connection or by USB link. Additional legally marketed components such as conventional X-ray tubes and image capture software that are currently available commercially can be used with the WDS X-POD and ZEN-X Digital X-Ray Sensors.
Device Description
The X-POD is comprised of the X-POD X-Ray sensitive digital sensor, with cable and connector, to be connected to a hand-held unit. X-POD X-ray Digital Sensor is a CMOS Sensor that receives the X-Ray image and converts it into an electronic format. The X-POD hand-held unit receives the X-ray images from the sensor and stores them on an secure digital card. It includes a color display with touch-screen capability. The display allows the user to check if the X-ray was correctly positioned on the image. It also includes an electronic board which allows the X-POD sensor to communicate with the PC through USB® and Bluetooth® links, and controls the display including the on-board circuits for charge control and monitoring the rechargeable battery. The X-POD handheld unit also includes an SD card to store the images. A Wall mount Battery Charger is used for recharge of the internal battery, or to operate the hand-held unit when the battery level is under a minimum value. The battery charger provides 9VDC, 1.5A. The rechargeable battery pack supplies the electricity to the electronic board and the sensor. The battery compartment is enclosed by a screwmounted panel and can only be replaced by qualified technicians (service). The battery charger is used for fast recharge of the internal battery, or to operate the hand-held unit when the battery level is under a minimum value. The battery charger provides 9VDC, 1.5A. The ZEN-X Sensor consists of the following components which are described in detail below: . ZEN-X Intraoral Sensor - ZEN-X interface . - CD-ROM with software, driver, and manuals . The ZEN-X intraoral sensor receives the X-ray image and converts it to an electronic format. The data from the X-ray image is transmitted from the sensor to the PC through the interface. The image data sent by the X-ray sensor is converted by the interface circuit into standard logic levels for the electronic circuit board to process the image data. The USB interface controls the flow of data and commands between the ZEN-X Interface and the computer. The ZEN-X Interface controls the timing and functions of the image data conversion and transmission.
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K Number
K101661Device Name
MYRAY HYPERION
Manufacturer
Date Cleared
2010-09-16
(94 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
CEFLA DENTAL GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cefla MyRay Hyperion is intended for use in producing panoramic-ray images of the maxillofacial region. It is used for the examination of teeth, the jaw, and oral structures.
Device Description
The MyRay Hyperion is a panoramic dental X-ray system which consists of a telescopic column, an overhead frame with a horizontal arm where an X-ray source and collimator and an X-ray image detector are mounted, and a console with a keyboard and display. The device includes a patient positioning system that consists of two handles which the patient grasps during exposures, a bite block, a frame for holding the head in the proper position and alignment with laser guide lights. The x-ray source and collimator generate a fan shaped x-ray beam which is projected through the patient's skull by the rotation of the imaging unit. The x-ray image detector allows reconstruction of the diagnostic image, storage of the image in the buffer memory, and transfer of the image to an external PC (not provided by Cefla).
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