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510(k) Data Aggregation

    K Number
    K042361
    Device Name
    DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D
    Manufacturer
    SEDECAL USA, INC.
    Date Cleared
    2004-09-29

    (29 days)

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

    SEDECAL USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for Use: Sedecal Portable X-Ray Units with Detector are 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.
    Device Description
    SPS-HF-4.0-D Portable X-ray Unit with Detector is a portable unit which operate from 120 V 50-60~ AC. The unit utilizes a high frequency inverter mounted to a tripod or support arm. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G.
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    K Number
    K012546
    Device Name
    OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
    Manufacturer
    SEDECAL USA, INC.
    Date Cleared
    2001-11-02

    (87 days)

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

    SEDECAL USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "Optima URS" Universal Radiographic System 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.
    Device Description
    The "Optima URS" is a stationary unit which operates from 120 V 50-60~ AC. Optima URS is a universal swivel arm X-ray system. It is easy to operate and permits a swift radiographic procedure, a feature which applies to all conventional exposure techniques on all parts of the body. The system is composed of a floor-to wall column and a turnable arm with variable high center. It allows one to take exposures of patients in standing, sitting or laying position. Owing to its compact design Optima URS is a low-cost radiography system which takes up little space and is quick to install.
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    K Number
    K012663
    Device Name
    EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)
    Manufacturer
    SEDECAL USA, INC.
    Date Cleared
    2001-08-31

    (18 days)

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

    SEDECAL USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "Easy Moving"M" Mobile X-ray Unit (Model SM-HF) 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.
    Device Description
    The "Easy Moving"M" Mobile X-ray Unit (Model SM-HF)" is a mobile unit which operates from 120 V 50-60~ AC or batteries. It is easy to operate and permits a swift radiographic procedure, a feature which applies to all conventional exposure techniques on all parts of the body. The system is composed of a base unit housing the high voltage generator and controls and a turnable arm with rotatable tube head. It allows one to take exposures of patients in standing, sitting or laying position. Owing to its compact design "Easy Moving™™ Mobile X-ray Unit is a low-cost radiography system which takes up little space and is quick to set up and operate.
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