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510(k) Data Aggregation

    K Number
    K031801
    Device Name
    PANTOS, MODELS: PANTOS 16, AND PANTOS DG
    Manufacturer
    Date Cleared
    2003-09-11

    (92 days)

    Product Code
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLUE X IMAGING SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PantOs equipment, model PantOs 16, and PantOs DG are indicated for individuals requiring extra-oral dental radiographic examinations and diagnosis of diseases of the teeth, jaw, and oral structures. It exposes and acquires radiographic images at the dentomaxillofacial region. Depending on the model, the anatomical structures are visualized either on a radiographic film or on a computer display, through a dedicated image-intensified fluoroscopic x-ray system.
    Device Description
    PantOs 16 is an X-ray equipment for dental panoramic radiography and for Cephalometry when completed with lateral arm (Ceph version. PantOs 16 has an X-ray generator with anodic voltage from 60 to 86 kV (constant potential), anodic current from 4 to 10 mA (direct current). Positioning the patient is done using a bite block or a chin rest, a few simple steps are required: once the height of the carriage is adjusted manually to bring the Frankfurt plane horizontally, correct rotation of the head is checked with the mirror. Front teeth alignment (to align to the in-focus-layer) is done by moving manually the carriage (backward or forward) till correct position is determined with the aid of the lateral light beam (the unit is adjusted without the need to move the patient). PantOs DG performs like PantOs 16 and is equipped with a digital panoramic receptor instead of film cassette, thus producing panoramic images on the display of a computer system.
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    K Number
    K031118
    Device Name
    INTRAOS 70
    Manufacturer
    Date Cleared
    2003-07-08

    (91 days)

    Product Code
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLUE X IMAGING SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IntraOs 70 (with Autoset Timer) is intended for the dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth. Such a device makes use of an extra oral source x-ray system commonly referred to as intraoral x-ray equipment.
    Device Description
    IntraOs 70 is a Dental X-Ray generator; its primary use is for intra oral image receptor radiology. For such application, a peak voltage of 70 kVp has been demonstrated to give a high quality film with a good film quality/risk ratio. The beam-limiting device is formed by a circular cone, which grants a source skin distance of 20cm and has a round output field of 6cm diameter. The weight of the tubehead is 6.4 kg. The certified components may be assembled in different configurations in terms of arms and mounting. Exposure times are microprocessor controlled, assuring a high constancy and also repeatability. The operator may choose exposure times from 60 ms to 3,2 s by object selection. Manual setting possibility or exposure time from 60 ms to 3,2 s (plus or minus, 18 steps: 0.06; 0.08; 0.10; 0.12; 0.16; 0.20; 0.25; 0.32; 0.40; 0.50; 0.64; 0.80; 1.00; 1.25; 1.60; 2.00; 2.50; 3.20 s) if required. Timer and hand switch can be remotely mounted. The hand-switch is provided with a 3 m-coiled cord.
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