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510(k) Data Aggregation

    K Number
    K160984
    Device Name
    MultiScan G-Arm System
    Date Cleared
    2016-07-20

    (104 days)

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

    BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The B5 S is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning operations in trauma surgery, orthopedics, spine surgery, and chest surgery. It is not intended to be used in interventional procedures. The B5 S permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients.
    Device Description
    The B5 S is a mobile digital X-ray diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery. It is not intended to be used in interventional procedures. There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately. The B5 S is comprised of control unit and G-Arm, the control unit and G-Arm include below primary components. Control Unit Major Component: Viewing monitor (2), Exposure lamp (2), Control monitor (1), Keyboard (1), Footswitch subassembly (1), Printer(optional) (1). G-Arm Major Component: Image intensifier assembly (2), X-Ray tube assembly (2), Laser light indicator(optional) (2), Steering unit (optional) (1).
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    K Number
    K160343
    Device Name
    SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner
    Date Cleared
    2016-04-07

    (59 days)

    Product Code
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Portable Ultrasound Diagnostic Scanner is intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdomen; Small Parts; Obstetrics; Gynecology; Cardiology; Peripheral Vessels; Urology; Pediatrics; Neonate; Trans-cranial; Musculoskeletal; Fetal; Intra-operative; Transvaginal.
    Device Description
    The Portable Ultrasound Diagnostic Scanner comprises of a console, a cart, an AC adaptor, and several transducers and printers. The console is a portable ultrasound diagnostic device with an integrated keyboard and LCD display. It is capable of digital acquisition, processing and display. The mobile cart with multiple socket-outlet and extension transducer connector improves the mobility by having all accessories on it.
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    K Number
    K131423
    Device Name
    G-ARM MULTISCAN SYSTEM
    Date Cleared
    2013-11-07

    (175 days)

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

    BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DigiArc 100AU is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. The DigiArc 100AU permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients at the age of at least eighteen.
    Device Description
    The DigiArc 100AU is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately.
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