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510(k) Data Aggregation

    K Number
    K110839
    Device Name
    SCANORA 3D
    Manufacturer
    SOREDEX PALODEX GROUP OY
    Date Cleared
    2011-06-30

    (97 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why 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
    K073350
    Device Name
    SCANORA 3D
    Manufacturer
    SOREDEX PALODEX GROUP OY
    Date Cleared
    2007-12-19

    (20 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why 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
    K070304
    Device Name
    DIGORA PCT/DIGIPOD
    Manufacturer
    SOREDEX PALODEX GROUP OY
    Date Cleared
    2007-03-27

    (55 days)

    Product Code
    MUH, EHD, MQB
    Regulation Number
    872.1800
    Why 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
    K063459
    Device Name
    CRANEX NOVUS
    Manufacturer
    SOREDEX PALODEX GROUP OY
    Date Cleared
    2006-12-26

    (41 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why 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
    K043307
    Device Name
    CRANEX D
    Manufacturer
    SOREDEX PALODEX GROUP OY
    Date Cleared
    2004-12-17

    (16 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why 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
    K040382
    Device 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
    872.1800
    Why 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
    K041050
    Device 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
    872.1800
    Why 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
    K033755
    Device Name
    MINRAY
    Manufacturer
    SOREDEX PALODEX GROUP OY
    Date Cleared
    2004-04-29

    (150 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why 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
    K012170
    Device Name
    DIGORA PCT
    Manufacturer
    SOREDEX PALODEX GROUP OY
    Date Cleared
    2001-08-10

    (29 days)

    Product Code
    MUH, EHD, MQB
    Regulation Number
    872.1800
    Why 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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