Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K063504
    Device Name
    ECONOLITH EM1000
    Manufacturer
    MEDISPEC, LTD.
    Date Cleared
    2007-03-09

    (109 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISPEC, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EM1000 is indicated for use in the non-invasive fragmentation of upper urinary tract stones, to include urinary stones located in the kidney (renal pelvis and renal calyces) and upper ureter.
    Device Description
    Medispec Ltd.'s Econolith™ EM1000 system is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The EM1000 device includes a shock wave generator which is based on an Electromagnetic shock wave head and is to be used in conjunction with a multi axes Motorized Treatment Table, a C-Arm X-ray/fluoroscope imaging unit, an ECG monitor, and an anesthesia apparatus, which may be supplied by the user. The device also contains the necessary interface for optional Ultrasonic imaging devices. The EM1000 includes the following components for patient handling, positioning and shock wave generation: - Shockwave Generator - Electromagnetic Shock wave head, - High-Voltage System. - Water System, - Treatment Table Control, - ECG System. - Control and Timing Circuitry, and - Front Panel Controls
    Ask a Question
    K Number
    K040461
    Device Name
    ECONOLITH E3000, MODEL 3000 (SW-6)
    Manufacturer
    MEDISPEC, LTD.
    Date Cleared
    2004-05-25

    (92 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISPEC, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Econolith™ E3000 is indicated for use in non-invasive fragmentation of upper urinary tract stones between 5 and 20 mm in size.
    Device Description
    Medispec Ltd.'s Econolith™ E3000 uses shock waves generated outside the patient's body to fragment urinary calculi within either the kidney or upper ureter. The device consists of an electrony draulic shock wave generator, control panel, and motorized patient table. Although the device does not provide imaging or monitoring functions, it does contain dedicated interfaces for the requisite fluoroscopic imaging and ECG monitoring. The shock wave generator is a self-contained unit which includes an underwater electrode, a control system, and a high voltage power supply system. The treatment table is specifically designed for use with the Econolith™ Lithotripter. The table can position the patient in multi-dimensions and also provides access to the patient's lumbar region through removable inserts.
    Ask a Question
    K Number
    K974796
    Device Name
    LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER
    Manufacturer
    MEDISPEC, LTD.
    Date Cleared
    1998-03-12

    (80 days)

    Product Code
    FFK
    Regulation Number
    876.4480
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISPEC, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LITHOSPEC™ Intracorporeal Lithotripter is intended to be used during urological procedures to crush and remove bladder, ureteral and renal stones.
    Device Description
    The LITHOSPECTM is a direct contact intracorporeal lithotripter which fragments bladder, ureteral and renal calculi by utilizing direct endoscopic techniques. The electromechanical technique ensures the delivery of high impact mechanical fragmentation power to the stone while eliminating the possibility of thermal injury. Four reusable Probes, having diameters: 0.8 mm, 1.6 mm, and 2.0 mm, are provided with the system. The LITHOSPEC™ is operated using standard endoscopic equipment.
    Ask a Question

    Page 1 of 1