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Found 9 results
510(k) Data Aggregation
K Number
K110839Device Name
SCANORA 3D
Manufacturer
SOREDEX PALODEX GROUP OY
Date Cleared
2011-06-30
(97 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
SOREDEX PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Scanora 3D is a Cone Beam 3D x-ray system for imaging the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. Dedicated panoramic imaging is an option. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by qualified healthcare professionals.
Device Description
Scanora 3D is a Cone beam 3D x-ray system for Dentomaxillofacial and Head & Neck (ENT) imaging. Dedicated panoramic imaging is an option. In CT mode it generates a conical x-ray beam during rotation around a patient's head and produces two dimensional projection images on a flat panel detector. Three dimensional images are then reconstructed and viewed with 3rd party software. In panoramic mode panoramic and TMJ images can be taken in the classical way on a separate CCD detector.
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K Number
K073350Device Name
SCANORA 3D
Manufacturer
SOREDEX PALODEX GROUP OY
Date Cleared
2007-12-19
(20 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SOREDEX PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Scanora 3D is a dental cone beam computed tomography x-ray system intended to image teeth, jaw and TMJ areas of the skull. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by dentists and other qualified professionals.
Device Description
Scanora 3D is a dental cone beam CT for imaging of teeth, jaw and TMJ areas of the skull. In CT mode it generates a pulsed conical x-ray beam during rotation around a patient's head and produces two dimensional images on a flat panel detector. Three dimensional images are then reconstructed and viewed with software. In panoramic mode panoramic and TMJ images can be taken in the classical way on a separate CCD detector.
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K Number
K070304Device Name
DIGORA PCT/DIGIPOD
Manufacturer
SOREDEX PALODEX GROUP OY
Date Cleared
2007-03-27
(55 days)
Product Code
MUH, EHD, MQB
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SOREDEX PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digora PCT or Digipod imaging system is indicated for capturing, digitization and processing of extraoral, maxillofacial, cephalometric and podiatric X-ray images stored in imaging plate recording media.
Device Description
A digital radiography system for imaging plates located in cassettes. The system may be used with x-ray equipment utilizing film or similar cassettes. The image is recorded on reusable imaging plate which substitutes for conventional x-ray film. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by pixel by a scanning laser. An optical system collects the emission for photoelectronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals.
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K Number
K063459Device Name
CRANEX NOVUS
Manufacturer
SOREDEX PALODEX GROUP OY
Date Cleared
2006-12-26
(41 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SOREDEX PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cranex Novus dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.
Device Description
Cranex Novus is a panoramic extraoral source dental x-ray system, which produces digital images of dentition. Cranex Novus utilizes digital image receptor(CCD). The technique factor settings for panoramic examinations are: 60 kVp or 70 kVp, 7 mA DC and max. 9 s.
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K Number
K043307Device Name
CRANEX D
Manufacturer
SOREDEX PALODEX GROUP OY
Date Cleared
2004-12-17
(16 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SOREDEX PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cranex D dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures. The Cranex D is upgradeable for cephalometric radiography and examinations related thereto.
Device Description
Cranex D is a panoramic extraoral source dental x-ray system, which produces digital images of dentition. The device is upgradeable for cephalometric radiography. Cranex D utilizes digital image receptor(CCD).
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K Number
K040382Device Name
CRANEX BASEX D OR CRANEX EXCEL D
Manufacturer
SOREDEX PALODEX GROUP OY
Date Cleared
2004-07-13
(147 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SOREDEX PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cranex Basex D and Cranex Excel D dental panoramic equipments are indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.
Device Description
Cranex Basex D and Cranex Excel D are panoramic extraoral source dental x-ray systems, which produce digital images of dentition. They are modified from the existing Soredex dental panoramic x-ray systems (K880982) by substantially replacing the film image receptor with a digital receptor(CCD). The technique factor settings are constant for the x-ray tube anode voltage (65kV) and current (6 mA DC),
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K Number
K041050Device Name
DIGORA OPTIME (OR DIGORA ONTIME)
Manufacturer
SOREDEX PALODEX GROUP OY
Date Cleared
2004-06-15
(54 days)
Product Code
MUH, EHD, MQB
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SOREDEX PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digora Optime imaging system is indicated for capturing, digitization and The Digora Optime Images stored in imaging plate recording media.
Device Description
A digital radiography system for intra oral imaging plates located in disposable bags. The system may be used with all x-ray equipment which is designed for intra oral radiography. The image is recorded on reusable imaging plate which substitutes for conventional x-ray film. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by pixel by a scanning laser. An optical system collects the emission for photo electronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals.
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K Number
K033755Device Name
MINRAY
Manufacturer
SOREDEX PALODEX GROUP OY
Date Cleared
2004-04-29
(150 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SOREDEX PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Minray dental x-ray system is intended to be used for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intraoral digital or film image receptor media.
The Minray dental x-ray system is indicated for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intra oral film or digital image receptor media.
Device Description
Minray is an extraoral source dental x-ray system, which produces dental images on intraoral digital or film image receptors. The x-ray generator operates on high frequency and has an DC output. There are two selectable anode voltages 60 kV and 70 kV. Anode current is constant 7 mA. Exposure time can be selected from 20 ms to 3.2 s.
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K Number
K012170Device Name
DIGORA PCT
Manufacturer
SOREDEX PALODEX GROUP OY
Date Cleared
2001-08-10
(29 days)
Product Code
MUH, EHD, MQB
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SOREDEX PALODEX GROUP OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digora PCT imaging system is indicated for capturing, digitization and processing of extraoral, maxillofacial and cephalometric x-ray images stored in imaging plate recording media.
Device Description
A digital radiography system for imaging plates located in cassettes. The system may be used with x-ray equipment utilizing film or similar cassettes. The image is recorded on reusable imaging plate which substitutes for conventional x-ray film. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by pixel by a scanning laser. An optical system collects the emission for photoelectronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals. Further image processing, display and achieving are carried out with an auxilia software (such as Digora for Windows K983267), a PC and a CRT.
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