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510(k) Data Aggregation

    K Number
    K090079
    Device Name
    VIVID, MODELS 40-A0001, 40-A0004, 40-A0006
    Manufacturer
    PROGENY, INC.
    Date Cleared
    2009-05-01

    (109 days)

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

    PROGENY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vivid Intraoral Video Camera is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures.
    Device Description
    The Progeny, Inc. Vivid Intraoral Video Camera is a state-of-the-art dental video camera. When used with a compatible software application, the operator will be able to capture and store video images into a patient's file.
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    K Number
    K070664
    Device Name
    PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).
    Manufacturer
    PROGENY, INC.
    Date Cleared
    2007-04-26

    (48 days)

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

    PROGENY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Progeny Imaging software is to act as a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.
    Device Description
    The Progeny, Inc. Progeny Imaging Software is a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.
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    K Number
    K043092
    Device Name
    PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015
    Manufacturer
    PROGENY, INC.
    Date Cleared
    2004-12-13

    (34 days)

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

    PROGENY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Progeny PREVA Extra-Oral X-Ray system is to act as a diagnostic source for radiographic dental imaging.
    Device Description
    The Progeny, Inc. PREVA Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral radiographs in dental diagnostic radiography. The system consists of the following main components: X-ray tubehead, Rotating yoke for tubehead mounting, Articulation arm, Horizontal extension arm, Electronic control unit, Wall mount, 8 inch cone. Optional Components include a 12 inch cone and an 8 ft. coil cord with exposure switch. The Power supply is regulated to provide a selectable 60, 65, or 70 kVp at a selectable tube current of 4, 6, or 8 mA. Predefined exposure times may be selected via the operator control panel. The range of exposure times is 0.01 to 2.00 seconds.
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    K Number
    K041831
    Device Name
    PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR
    Manufacturer
    PROGENY, INC.
    Date Cleared
    2004-08-09

    (33 days)

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

    PROGENY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Progeny MPSe system is intended to use for acquisition of digital images of intra-oral anatomy of interest to a computer for display by Ethernet.
    Device Description
    The X-ray MPS system is an intraoral receiver of the X-ray energy used by the dentist r ne A Tay NT & Systemler as vity. The MPSe sensor consists of 3 pieces: an X-ray to image toom an X-ray sensor driver and a power supply. The Progeny MPSe Intraoral X-ray System consists of the following main components: Sensor X-Ray sensor driver Power Supply
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    K Number
    K020070
    Device Name
    JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002
    Manufacturer
    PROGENY, INC.
    Date Cleared
    2002-02-01

    (23 days)

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

    PROGENY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Progeny JB-70 Intra Oral X-Ray System is to act as a diagnostic source for radiographic dental imaging.
    Device Description
    The Progeny, Inc. JB-70 Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral radiographs in dental diagnostic radiography. The Progeny, Inc. JB-70 Intraoral Dental X-Ray System consists of the following main components: X-ray tubehead, Rotating yoke for tubehead mounting, Articulation arm, Horizontal extension arm, Electronic control unit, Wall mount, 8 inch cone. Optional Components: 12 inch cone, 8 ft. coil cord with exposure switch. The Power supply is regulated to provide a fixed 70 kVp at a fixed tube current of 8 mA. Predefined exposure times may be selected via the operator control panel. The range of exposure times is 0.05 to 1.65 seconds.
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