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510(k) Data Aggregation

    K Number
    K142930
    Device Name
    Exam Vue DR
    Manufacturer
    JPI HEALTHCARE CO., LTD
    Date Cleared
    2015-04-17

    (190 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    JPI HEALTHCARE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Exam Vue DR is a software for the acquisition, processing, storage and viewing of two-dimensional digital radiology images. Exam Vue DR is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects. ExamVue DR is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. ExamVue DR is not indicated for use in mammography.
    Device Description
    The Exam Vue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3tt party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.
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    K Number
    K102327
    Device Name
    CLEARVISION DR 7000F
    Manufacturer
    JPI HEALTHCARE CO., LTD
    Date Cleared
    2012-04-13

    (605 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    JPI HEALTHCARE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clear Vision DR7000F product is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column,. chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The Clear Vision DR7000F system is intended to be used in medical clinics and hospitals for emergency, orthopedic, chiropractic, and other medical purposes. This device is not indicated for use in mammography.
    Device Description
    The Clear Vision DR7000F system is a high-resolution digital imaging system designed for digital radiography. It is designed to replace conventional film radiography techniques. This system consists of a tube head/collimator assembly mounted on a U-Arm, along with a generator, generator control, and a detector, operating software. The detector which is used proposed device is LTX240AA01-A (K090742) and LLX240AB01 (K102587) of Samsung Mobile Display Co., Ltd. These detectors are cleared by FDA 510(k).
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    K Number
    K101779
    Device Name
    CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
    Manufacturer
    JPI HEALTHCARE CO., LTD
    Date Cleared
    2011-05-16

    (325 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    JPI HEALTHCARE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clear Vision DR 2000 product is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column,, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The Clear Vision DR 2000 system is intended to be used in medical clinics and hospitals for emergency, orthopedic, chiropractic, and other medical purposes. This device is not indicated for use in mammography.
    Device Description
    The Clear Vision DR2000 system is a high-resolution digital imaging system designed for digital radiography. It is designed to replace conventional film radiography techniques. This system consists of a tube head/collimator assembly mounted on a U-Arm, along with a generator, generator control, and a detector, operating software. The detector which is used proposed device is QXR9 (K073056) and QXR16 (K080553) of Vieworks Co., Ltd. These detectors are cleared by FDA 510(k).
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    K Number
    K955706
    Device Name
    JPI AUTOMATIC X-RAY FILM PROCESSOR
    Manufacturer
    JPI HEALTHCARE CO., LTD
    Date Cleared
    1996-02-12

    (59 days)

    Product Code
    IXW
    Regulation Number
    892.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    JPI HEALTHCARE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954161
    Device Name
    JPI INTENSIFYING SCREEN
    Manufacturer
    JPI HEALTHCARE CO., LTD
    Date Cleared
    1996-02-02

    (150 days)

    Product Code
    EAM
    Regulation Number
    892.1960
    Why did this record match?
    Applicant Name (Manufacturer) :

    JPI HEALTHCARE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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