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510(k) Data Aggregation

    K Number
    K173319
    Device Name
    KaVo NOMAD Pro 2 Handheld X-ray System
    Manufacturer
    Aribex
    Date Cleared
    2017-11-16

    (27 days)

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

    Aribex

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KaVo NOMAD Pro 2 Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.
    Device Description
    KaVo NOMAD Pro 2 Handheld X-ray System is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The KaVo NOMAD Pro 2 Handheld X-ray System is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safequards are implemented. The device uses a rechargeable battery to allow for the use of the KaVo NOMAD Pro 2 Handheld X-ray System where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility. The KaVo NOMAD Pro 2 Handheld X-ray System is an X-ray device with a DC qenerator. The handheld device features a main unit (tube head), recharqeable battery (handset), charger, and charger AC/DC power supply. The power is supplied by a rechargeable Lithium Ion battery core pack built into a handset. This facilitates portability of the device. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient. To make the system as simple as possible for the operator, KaVo NOMAD Pro 2 Handheld Xray System uses a fixed tube voltage of 60kV and a fixed tube current of 2.5mA. The only operator-adjustable parameter is the exposure time. This adjustment can be quickly accomplished through the user-friendly control panel. Control buttons, display, and a trigger provide the primary operator interface. Exposures settings can be selected and displayed. Voltage (60 kV) and current (2.5 mA) are fixed with the exposure time varying based on patient type, detector type, and anatomical feature. Exposures can be completed using the trigger. The device can be used with three detector types: film, digital imaging intraoral sensors, and phosphor plates.
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    K Number
    K140723
    Device Name
    NOMAD MD 75K V HANDHELD X-RAY SYSTEM
    Manufacturer
    ARIBEX, INC.
    Date Cleared
    2014-08-19

    (151 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARIBEX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NOMAD MD is a handheld and portable general purpose X-ray system. The device uses a fixed tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities. It is intended to be used by a qualified and trained clinician on both adult and pediatric patients. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.
    Device Description
    The NOMAD MD is a handheld, general purpose X-ray system that operates on 14.4 V DC supplied by a rechargeable NiCd battery pack. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery, a Charging Cradle, and an AC-to-DC Power Supply.
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    K Number
    K081664
    Device Name
    NOMAD PRO X-RAY SYSTEM
    Manufacturer
    ARIBEX, INC.
    Date Cleared
    2008-06-23

    (10 days)

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

    ARIBEX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NOMAD Pro X-ray System is intended to be used by trained dentists and dental technicians as an extraoral X-ray source for producing diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects. The NOMAD Pro X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce Xray images using intraoral image receptors.
    Device Description
    NOMAD Pro is a handheld dental X-ray system that operates on 22.2 V DC supplied by a rechargeable Lithium Polymer battery pack enclosed in a Handset. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes a spare battery Handset, a Charging Cradle, an AC-to DC Power Supply, and a permanently attached Backscatter Shield.
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    K Number
    K051795
    Device Name
    NOMAD DENTAL X-RAY SYSTEM
    Manufacturer
    ARIBEX, INC.
    Date Cleared
    2005-07-14

    (9 days)

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

    ARIBEX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NOMAD™ DENTAL X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental x-ray source to produce x-ray images using intraoral image receptors.
    Device Description
    NOMAD™ Dental is a portable dental x-ray system that operates on 14.4 V DC supplied by a rechargeable NiCd battery pack. The x-ray tubehead, x-ray controls, and power source are assembled into a single handtubenoud, A ray controlage includes spare batteries, a battery charger, and a backscatter shield.
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