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510(k) Data Aggregation

    K Number
    K972019
    Device Name
    PEFECT SHOT
    Date Cleared
    1997-07-03

    (32 days)

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

    INTERNATIONAL IMAGING ELECTRONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Perfect Shot Intra-Oral Camera is to be used by medical practitioners, usually dental hygienists, assistants or dentlats, to view the mouth of patients. It can explore the entire mouth and examine teeth or gum tissue for diagnostic purposes. It is distributed through dealers to medical practitioners. The Perfect Shot is wireless, unlike other similar devices, allowing more freedom of movement by the user. It also contains voice activated instructions which enable the user to "freeze" a view on the monitor or take a picture and print) of the area being examined for reference at a later date by simply using voice instructions. The product is designed to transmit a RF (radio frequency) signal to a receiver. This product can and will be used both intra and extra orally, which will allow a dentist to examine and display to the patient problem areas of concern or treatment that is required. The resolution capabilities of the CCD (Charge Coupled Device) is 640-480 lines. The picture is transmitted to a monitor in the examination area for the patient to view , allowing the patient a better understanding of a potential problem and a better explanation of the prescribed solution. Pictures that are captured may be printed for further review or for patient files. The Perfect Shot may also be attached to computers for digital storage or transmission to other computers.
    Device Description
    The Perfect Shot Intra-Oral Camera is a wireless intra-oral camera that transmits an RF signal to a receiver. It has voice activated instructions to freeze a view or take a picture. It uses a CCD with 640-480 lines resolution. The picture is transmitted to a monitor and can be printed or attached to computers for digital storage or transmission.
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    K Number
    K970964
    Device Name
    MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM
    Date Cleared
    1997-06-13

    (88 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL IMAGING ELECTRONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended to be used by all medical and dental personnel to store all patient medical or dental records on CD, Digital Audio Tapes or any future digital archivable media. The Maestro product is capable of transmitting patient records or claims to third party administrators or insurance companies for processing of patient insurance claims. Maestro allows a user to use digital zoom-in features to enlarge an x-ray film/images, or any type of document for closer examination.
    Device Description
    Not Found
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    K Number
    K950330
    Device Name
    DIGITAL IMAGE ACQUISITION SYSTEM
    Date Cleared
    1996-05-07

    (466 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL IMAGING ELECTRONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K953165
    Device Name
    ULTRA COMPACT VIDEO IMAGER
    Date Cleared
    1996-05-07

    (305 days)

    Product Code
    Regulation Number
    892.2040
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL IMAGING ELECTRONICS

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