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510(k) Data Aggregation

    K Number
    K221233
    Device Name
    DT-703
    Manufacturer
    ECOTRON Co., Ltd
    Date Cleared
    2022-06-27

    (59 days)

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

    ECOTRON Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DT-703 is a portable dental X-ray system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use DT-703 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
    Device Description
    DT-703 is a handheld X-ray system powered by a rechargeable Li-ion polymer battery pack. DT-703 is an extra source X-ray generating device that is mainly designed for dental examination (on teeth, etc.). DT-703 is composed of X-ray generator with X-ray tube including device controller, power controller, user interface, beam limiting part, backscatter shielding glass, and optional remote exposure switch. DT-703 is designed to diagnose teeth and jaw through X-ray irradiation using an intra-oral image receptor. DT-703 is controlled by software (firmware) and the software level of concern is Moderate. The x-ray image detector (an integral part of a complete dental diagnostic system) is not part of the DT-703 X-ray device.
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    K Number
    K180473
    Device Name
    ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR
    Manufacturer
    ECOTRON Co., Ltd
    Date Cleared
    2018-03-23

    (29 days)

    Product Code
    OWB, JAA, OXO
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECOTRON Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANY VIEW DR SERIES (Anyviw-500DR, Anyview-240DR) is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures. This system can be applied in emergency room, operation room, cast room or etc. of hospital.
    Device Description
    The ANYVIEW DR SERIES (Anyviw-500DR, Anyview-320DR, Anyview-240DR) are mobile x-ray fluoroscopic imaging systems used by radiation experts. ANYVIEW DR SERIES are a digital fluoroscopic imaging systems with Flat Panel Detector (FPD) used in diagnostic and interventional procedures. ANYVIEW DR SERIES are composed of C-arm, x-ray generating equipment (x-ray controller, high voltage generator, x-ray tube, motor-type collimator), FPD, and workstation (console computer and monitor). ANYVIEW imaging software is a Digital Imaging System (DIS) designed for C-arm, ANYVIEW FPD Fluoroscopic Mobile X-ray System. ANYVIEW imaging software provides useful functions to manage X-ray images obtained from ANYVIEW DR SERIES FPD Fluoroscopic Mobile X-ray System. ANYVIEW imaging software provides various image tools. One of the most noticeable features is that the C-arm imaqes taken during an exam are stored in the database for further review. I Image data is integrated with the patient information in DICOM(OPTION) compatible format which allows compatibility with existing DICOM and PACS system.
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