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510(k) Data Aggregation

    K Number
    K170066
    Device Name
    Green16/Green18 (Model: PHT-65LHS)
    Manufacturer
    VATECH CO., LTD.
    Date Cleared
    2017-06-16

    (158 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    VATECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PHT-65LHS is intended to produce panoramic, cephalometric or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, ENT, sinus and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.
    Device Description
    Green16 / Green18 (Model: PHT-65LHS) is an advanced 5-in-1 digital X-ray imaging system that incorporates PANO, CEPH (Optional), CBCT, 3D MODEL Scan and 3D PHOTO (Optional) imaging capabilities into a single system. PHT-65LHS, a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists and ENT specialists. PHT-65LHS is a complete digital X-ray system equipped with imaging viewers, X-ray generator and a dedicated SSXI detector. The digital CBCT system is based on a CMOS digital X-ray detector. The CMOS CT detector is used to capture 3D radiographic images of head, neck, oral surgery, implant and orthodontic treatment. PHT-65LHS can also acquire 2D diagnostic image data in conventional panoramic and cephalometric modes.
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    K Number
    K132983
    Device Name
    TON-95LH, PAX-I3D ORTHO
    Manufacturer
    VATECH CO., LTD.
    Date Cleared
    2014-08-07

    (318 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    VATECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PaX i3D Ortho (TON-95LH) is a computed tomography x-ray system intended to produce cross-sectional images of the oral anatomy by reconstructing a three dimensional radiographic images from the same axial plane taken at different angles. It provides diagnostic details of the maxillofacial areas for a dental treatment in adult and pediatric dentistry. The system also acquires carpal images for orthodontic treatment. The device is operated and used by physicians, dentists, and x-ray technicians.
    Device Description
    PaX-i3D Ortho (TON-95LH) is a dental radiographic imaging system with cone beam computed tomography (CBCT) to offer high definition digital diagnostic images in multi FOV for dental practitioners. Specifically designed for dental radiography of the teeth or jaws, TON-95LH is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental CBCT radiography. The PaX-i3D Ortho (TON-95LH) dental CBCT system is equipped with a CMOS digital Xray detector which is used to capture radiographic diagnostic image data of oral and maxillofacial anatomy and reconstruct a three dimensional (3D) image for dental treatments such as oral surgery, implant and orthodontic. The PaX-i3D Ortho (TON-95LH) dental CBCT system also can reconstruct 2D panoramic and cephalometric images from the same diagnostic image data which the system originally obtained.
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    K Number
    K130585
    Device Name
    PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
    Manufacturer
    VATECH CO., LTD.
    Date Cleared
    2013-07-15

    (132 days)

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

    VATECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PCH-2500 is a digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, x-ray technicians and other professionals licensed by the law of the state in which the device is used.
    Device Description
    PCH-2500 is a dental digital radiographic imaging system which is available in two different image acquisition modes. Specifically designed for dental radiography of the teeth or jaws. PCH-2500 can be equipped with four dedicated sensors for two different X-ray modalities : one panoramic (Xmaru1501CF), two cephalometric scan type (Xmaru2301CF and Xmaru3001CF) and three flat panel one shot ceph sensors (1210SGA, 910SGA and 1417PGA). The proposed device is available with two X-ray generator options. PCH-2500 offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 imaging mode provides a wide range of imaging options based on the patient diagnostic needs.
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    K Number
    K130432
    Device Name
    PHT-6500, PHT-60CFO
    Manufacturer
    VATECH CO., LTD.
    Date Cleared
    2013-05-31

    (99 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    VATECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PHT-6500 (PHT-60CFO) is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry . The device is operated and used by physicians, dentists, and x-ray technicians.
    Device Description
    PHT-6500 (PHT-60CFO), a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometire and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-6500 (PHT-60CFO) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector. The proposed device is available with two X-ray generator options. - A pair of CT sensor and Pano sensor are assembled together, back to back, and fixed mechanically to the rotating X-ray gantry, facing the X-ray tube from the opposite side. Based on the choice of a modality, between CT and panorama, the mechanically attached sensors rotate automatically so an appropriate type of sensor is facing the X-ray tube for exposure. - The type of CT sensor attached to the equipment determines the model name. The model name, PHT-6500, refers to the equipment mounted with Xmaru0712CF, and Xmaru1215CF Plus SSXI detector whereas PHT- 60 CFO model refers to the equipment mounted with Xmaru1215CF Master Plus and Xmaru1524CF Master Plus SSXI detector.
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    K Number
    K123493
    Device Name
    VEX-S 100W INTRAORAL X-RAY SYSTEM
    Manufacturer
    VATECH CO., LTD.
    Date Cleared
    2012-12-13

    (34 days)

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

    VATECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VEX-S100W is an extraoral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures.
    Device Description
    VEX-S100W is an extraoral source dental X-ray system intended for intraoral imaging. It consists of X-ray generator, X-ray controller, beam limiting device, operation panel and mechanical arm. The X-ray controller allows for accurate exposure control, and an adjustable mechanical arm allows for easy positioning. The system can be used either with conventional film or a digital imaging system.
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    K Number
    K122155
    Device Name
    PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
    Manufacturer
    VATECH CO., LTD.
    Date Cleared
    2012-09-04

    (46 days)

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

    VATECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PCH-2500 (PaX-i) is a digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, x-ray technicians and other professionals licensed by the law of the state in which the device is used.
    Device Description
    PCH-2500 (PaX-i) is a dental digital radiographic imaging system which is available in two different image acquisition modes. Specifically designed for dental radiography of the teeth or jaws, PCH-(PaX-i) can be equipped with four dedicated sensors for two different X-ray modalities : one panoramic (Xmaru1501CF), one cephalometric scan type (Xmaru2301CF) and two flat panel one shot ceph sensors (1210SGA and 910SGA). PCH-2500 (PaX-i) offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 (PaX-i) imaging mode provides a wide range of imaging options based on the patient diagnostic needs.
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    K Number
    K121400
    Device Name
    PAX-UNI3D, PHT-7500
    Manufacturer
    VATECH CO., LTD.
    Date Cleared
    2012-08-28

    (110 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    VATECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PaX-Uni3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
    Device Description
    PaX-Uni3D (PHT-7500), a dental radiographic imaging system, consists of dual image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PaX-Uni3D (PHT-7500) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector.
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    K Number
    K121412
    Device Name
    PAX-FLEX3D, PHT-7000
    Manufacturer
    VATECH CO., LTD.
    Date Cleared
    2012-06-08

    (28 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    VATECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PaX-Flex3D is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry. The device is operated and used by physicians, dentists, and x-ray technicians.
    Device Description
    PaX-Flex3D (PHT-7000), a dental radiographic imaging system, consists of dual image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PaX-Flex3D (PHT-7000) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector.
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    K Number
    K121236
    Device Name
    PAX-DUO3D PLUS, PCT-5000
    Manufacturer
    VATECH CO., LTD.
    Date Cleared
    2012-05-24

    (30 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    VATECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PaX-Duo3D Plus is a computed tomography x-ray system intended to take panoramic and cross-sectional images of the oral and craniofacial anatomy to provide diagnostic information for adult and pediatric patients. The device is operated and used by physicians, dentists, dental assistants, x-ray technicians and other professionals who are licensed by the law of the State in which he or she practices to use the device.
    Device Description
    PaX-Duo3D Plus (PCT-5000), a dental radiographic imaging system, consists of dual image acquisition modes; panorama, and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PaX-Duo3D Plus (PCT-5000) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic dental x-ray system based on CMOS X-ray detector.
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    K Number
    K113672
    Device Name
    PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
    Manufacturer
    VATECH CO., LTD.
    Date Cleared
    2012-03-27

    (105 days)

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

    VATECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PCH-2500 is digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, x-ray technicians and other professionals licensed by the law of the state in which the device is used.
    Device Description
    PCH-2500 is a dental digital radiographic imaging system which is available in two different image acquisition modes. Specifically designed for dental radiography of the teeth or jaws, PCH-2500 can be equipped with three dedicated sensors, each for two X-ray modalities : panoramic (Xmarul 501CF), cephalometric scan type (Xmaru2301CF) and oneshot ceph sensor type (1210SGA). PCH-2500 offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 imaging mode provides a wide range of imaging option based on the customer's diagnostic needs.
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