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510(k) Data Aggregation

    K Number
    K111361
    Device Name
    PLANMED NUANCE EXCEL
    Manufacturer
    PLANMECA USA, INC.
    Date Cleared
    2011-09-23

    (130 days)

    Product Code
    MUE
    Regulation Number
    892.1715
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANMECA USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmed Nuance Excel is a FFDM (Full Field Digital Mammography) X-ray unit, which is intended to be used for screening and diagnosis of breast cancer in the same clinical applications as traditional film/screen mammography X-ray units. The system generates digital mammograms which enable to detect breast cancer at an early stage. The use of Planmed FFDM X-ray unit is allowed only under supervision of a health care professional.
    Device Description
    The Planmed Nuance Excel is a Full Field Digital Mammography (FFDM) system for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Planmed Nuance utilizes an amorphous selenium based digital image receptor to capture digital images. The receptor directly converts the incoming X-ray photons to digital image data. The workflow with Planmed Nuance Excel is controlled from the acquisition workstation and Planmed Nuance Manager 3 image acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS, respectively), as a format of modality work list. Subsequently, the images are acquired, processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.
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    K Number
    K081699
    Device Name
    PLANMECA SOVEREIGN
    Manufacturer
    PLANMECA USA, INC.
    Date Cleared
    2008-08-29

    (73 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANMECA USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmeca Sovereign is a dental operative unit, which is an ACpowered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device includes a dental patient chair, which is intended to properly position a patient to perform different dental procedures. The device is to be operated and used by dentists and other legally qualified professionals.
    Device Description
    The Planmeca Sovereign is a dental operative unit including a dental patient chair. The design is very flexible with many motorized functions, and both left-handed and righthanded use is easily obtainable. The dentist and assistant are allowed to change their working postures according to the operation to be performed. The versatile swivelling enables fluent two-handed and four-handed treatment sequences. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease-of-use. The instrument console includes six instrument locations, with easy instrument interchange.
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