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510(k) Data Aggregation

    K Number
    K113855
    Device Name
    PANORAD, PANORAD SL
    Manufacturer
    IMIX ADR FINLAND OY
    Date Cleared
    2012-01-25

    (27 days)

    Product Code
    KPR, LLZ, MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMIX ADR FINLAND OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IMIX PanoRad and PanoRad SL X-Ray Systems are indicated for use in generating radiographic images of human anatomy. They have Solid State X-ray Imaging systems intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)
    Device Description
    The modified device can produce digital x-ray images in various configurations.
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    K Number
    K101435
    Device Name
    IMIX PANORAD AND SOMARAD
    Manufacturer
    IMIX ADR FINLAND OY
    Date Cleared
    2010-09-15

    (117 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMIX ADR FINLAND OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IMIX PanoRad and SomaRad X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)
    Device Description
    The PanoRad consists of: A high resolution CCD detector with 14" x 17" or 17" x 17" image area. An X-Ray Tube & Collimator. A fully motorized positioned. A 65 kW high frequency generator. A 4 way floating table. An Image Acquisition workstation with DICOM 3 compliance. The SomaRad consists of: A high resolution CCD detector with 14" x 17" or 17" x 17" image area. An X-Ray Tube & Collimator. A fully motorized positioned. A 50 kW high frequency generator. A table. An Image Acquisition workstation with DICOM 3 compliance.
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    K Number
    K073114
    Device Name
    IMIX INSIGHT X-RAY SYSTEMS
    Manufacturer
    IMIX ADR FINLAND OY
    Date Cleared
    2008-01-17

    (73 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMIX ADR FINLAND OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IMIX Insight X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. IMIX Insight X-Ray Systems are not indicated for diagnostic X-ray mammography.
    Device Description
    System Features - URS Radiographic Stand . - Fully motorized movements with intelligent anti-collision system . - Automatic settings for 40 and 72 inch SID, auto-position for table exposures . - Patient Table capacity of 440 lbs . - Collimator with light field and laser positioning . - X-Ray Subsystem 65 kW High Frequency Compact Generator . - Full Anatomical Programming . - Automatic Exposure Control . - High Capacity (300kHU) X-ray tube with 0.6/1.2mm focus (27/75kW) . - Microprocessor System Monitor . - IMIX Insight Detector: High Resolution 9 megapixel or 16 megapixel CCD detector . - 40cm x 40cm Image Format (16 x 16 inch) . - Spatial Resolution: >3.1 1p/mm (4Mp) or >4.3 1p/mm (16Mp) . - Image Acquisition: 16 bit . - 3 Field Ionization Chamber .
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    K Number
    K072867
    Device Name
    IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K
    Manufacturer
    IMIX ADR FINLAND OY
    Date Cleared
    2007-11-21

    (47 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMIX ADR FINLAND OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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