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510(k) Data Aggregation
K Number
K983267Device Name
DIGORA FOR WINDOWS 2.0
Manufacturer
ORION CORPORATION SOREDEX
Date Cleared
1998-12-30
(104 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
ORION CORPORATION SOREDEX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digora for Windows 2.0 is a software device intended to using and managing dental x-ray images sent by Digora imaging plate scanner, storing the images and allowing the user to process and examine the images in order to achieve improved diagnoses. The software can also innager other imaging devices such as larger size imaging plate scanners and intraoral video cameras.
Device Description
Digora for Windows 2.0 is a dental imaging, image processing and archiving software, mainly to be used with Soredex Digora scanner (K934949). With this software is is possible to scan intra oral images using the Digora scanner, perform functions like edge enhancement, 3D emboss, density and contrast manipulation, length and angulation measurement with the image. The software also archives the images in the database, from where images can be stored in image media like CD-rom's.
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K Number
K974877Device Name
CRANEX TOME CEPH, OR CRANEX TOME
Manufacturer
ORION CORPORATION SOREDEX
Date Cleared
1998-03-27
(88 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
ORION CORPORATION SOREDEX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tomographic X-ray System, which is intended for diagnostic dental radiography at the dento-maxillofacial region and additionally cephalometry. The imaging methods are narrow beam radiography and spiral tomography and central projection cephalometry.
Device Description
Cranex Tome Ceph is a high frequency Tomographic, Radiographic system capable of producing dental panoramic and tomographic images, TMJ (TemporoMandibular Joint) tomographic images and cephalometric images. It is available in two models with (Cranex Tome Ceph) and without (Cranex Tome) the cephalometric option. The Cranex TOME uses the principle of autotomography with a spiral blurring movement. This movement, which is similar to the movement used by the Soredex SCANORA®, is achieved by tilting and rotating the C-arm at the same time.
The Cranex Tome comprises of
- moving column
- C-arm
- An adjustable two-position chin support is used to carry out all exposure procedures.
- Four-point head support and bite-block system
- A large adjustable mirror
- The patient positioning lights
- control panel
- graphical display
- wide range of x-ray programs for mandible, maxilla, temporomandibular joint,
sinus, and cephalometric exposures.
- high-frequency generator
-15x30 cm panoramic cassette for paroramic and tomographic imaging
And the following with the cephalometric unit
- Soft tissue filter adjustment with LED positioning indicators
- selectable magnification ratio and a rotatable head support with positioning stops every 45 degrees.
-The system software makes it impossible to take an exposure if the cephalometric cassette is the wrong size or incorrectly positioned.
-Accepts 18x24, 8"x10" or 24x30 cm cephalometric cassettes
- The cephalometric arm can be mounted on either the left- or the right-hand side of the unit
-An cephalometric kit is available so that Cranex TOME can be upgraded to a Cranex TOME Ceph .
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