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510(k) Data Aggregation

    K Number
    K242922
    Device Name
    Extracorporeal Shock Wave Lithotripter (U200)
    Manufacturer
    Shenzhen Wikkon Precision Technologies Co., Ltd.
    Date Cleared
    2025-06-18

    (267 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Why did this record match?
    Product Code :

    LNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extracorporeal Shock Wave Lithotripter, model: U200, is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
    Device Description
    The Extracorporeal Shock Wave Lithotripter, U200, is intended to treat urinary tract stones using ESWL. The Extracorporeal Shock Wave Lithotripter generates high-energy shock waves using a shock wave generator that is focused to produce a highly concentrated stress area at the focal point. These pressure pulses are focused on a specific point in the body where the Urinary calculi are located using assisted movement and manual localization through B-ultrasound. The pressure generated by the shock wave causes the human urinary tract stones to produce physical effects to achieve the therapeutic purpose of crushing stones. The Extracorporeal Shock Wave Lithotripter, U200, is composed of main unit, control console, patient table, electrical cabinet, power supply unit, and computer. Control platform is integrated control of electric cabinet, main engine and treatment bed. Electrical cabinet is used to provide power control of the whole machine, and shock wave source function control. Main Unit contains the L-shape arm and the support matrix of the impact wave source, and realize the movement of L-shape arm up and down, rotation and oscillation of the impact wave source inside and outside. Power box is power supply of the whole machine, power supply input voltage 120 V, 60 Hz, 3000VA. Treatment bed is used for patient support and treatment position, and provides three-dimensional movement to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures. PC(OptiPlex 7000 Tower) is used for installation of Extracorporeal Shock Wave Lithotripter Computer Control System, and to realize the Movement Control Support Function and the calibration of shock wave target, and image handling. Principle of operation: The extracorporeal shock wave lithotripter generates pressure pulses using an electromagnetic shock wave generator, with water serving as the transmission medium. These high energy shock waves with peak acoustic pressure up to 35MPa are focused on a specific point using a lens. In addition, the lithotripter often incorporates an ultrasound-based assisted movement system which locates and aligns the shock wave focus with the urinary tract stone. The shock waves create a stress effect on the stone. After several hundred to around two thousand discharges, the stones are fragmented into smaller pieces which can be excreted from the body.
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    K Number
    K221903
    Device Name
    Delta III Pro
    Manufacturer
    Dornier MedTech America, Inc
    Date Cleared
    2023-02-22

    (237 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Why did this record match?
    Product Code :

    LNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Delta III Pro Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.
    Device Description
    The Delta III Pro Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III is composed of the following modules: - . Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; - Patient Table: . - Control Desk/Image Storage (UIMS). . The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service. The therapy and X-ray C-arm house the shock wave source ("EMSE") and the complete X- ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, a flat panel image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones. The Delta III Pro's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures. The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-rav control and image handling.
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    K Number
    K213772
    Device Name
    LM-9300 Plus Lithotripter
    Manufacturer
    Lite-Med Inc.
    Date Cleared
    2023-01-19

    (413 days)

    Product Code
    LNS, INS
    Regulation Number
    876.5990
    Why did this record match?
    Product Code :

    LNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lite-Med LM-9300 Plus Lithotripter is indicated for fragmentation of kidney stones and renal pelvic stones and for upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL).
    Device Description
    The Lite-Med LM-9300 Plus is an Electromagnetic Extracorporeal Shock Wave Lithotripter that effectively treats urinary calculi. It is routinely used for the fragmentation of kidney and ureteral stones and offers a good combination of clinical performance, flexibility and affordability. The standard LM-9300 Plus system consists of a shockwave generator, an operator interface (industrial PC with dual monitors), a water circulation subsystem and a patient handling subsystem. For the Extracorporeal Shock Wave Lithotripsy (ESWL) operation to be fully functional, two more optional subsystems are necessary. The first is a C-arm X-ray fluoroscopy device and the second is an ultrasound imaging unit. Normally one of the imaging devices is sufficient. For most advanced ESWL designs such as LM-9300 Plus both X-ray and ultrasound are used for patient positioning and monitoring purposes. Shock waves are generated on the basis of a principle similar to that used in loudspeakers. An electrical impulse is sent through an inductance coil, generating a magnetic field which repulses a metallic membrane. The acoustic impulse created by this repulsion is focused by an acoustic lens to form a shock wave. A water circulation subsystem is used to provide transmission of shockwaves and cooling of the generator.
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    K Number
    K201001
    Device Name
    Modulith SLX-F2
    Manufacturer
    KARL STORZ Endoscopy America
    Date Cleared
    2021-03-30

    (348 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Why did this record match?
    Product Code :

    LNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STORZ MEDICAL Lithotripter Model MODULITH® SLX-F2 is indicated for the use in the noninvasive fragmentation of calculi in the kidney, in upper, middle and lower ureter for all adults and children 3 years or over.
    Device Description
    The MODULITH® Lithotripter SLX-F2 is an Extracorporeal Shock Wave Lithotripter Device. It generates shock waves that are focused onto the urinary calculi so that the stone fragments can be passed with the patient's urine.
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    K Number
    K201074
    Device Name
    Delta III Lithotripter
    Manufacturer
    Dornier MedTech America, Inc.
    Date Cleared
    2020-09-03

    (134 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Why did this record match?
    Product Code :

    LNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.
    Device Description
    The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; Patient Table; Control Desk/Image Storage (UIMS).
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    K Number
    K172084
    Device Name
    Delta III Lithotripter
    Manufacturer
    Dornier MedTech America, Inc.
    Date Cleared
    2017-08-08

    (29 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Why did this record match?
    Product Code :

    LNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.
    Device Description
    The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III is composed of the following modules: - . Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; - Patient Table; - . Control Desk - Image Processing. The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service. The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete Xray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones. The Delta III's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures. The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.
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    K Number
    K170122
    Device Name
    Delta III Lithotripter
    Manufacturer
    Dornier MedTech America
    Date Cleared
    2017-06-28

    (166 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Why did this record match?
    Product Code :

    LNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.
    Device Description
    The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III Lithotripter is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; Patient Table; Control Desk Image Processing.
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    K Number
    K151298
    Device Name
    Gemini XXP-HP
    Manufacturer
    Dornier MedTech America
    Date Cleared
    2015-07-30

    (76 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Why did this record match?
    Product Code :

    LNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gemini XXP-HP is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.
    Device Description
    The Gemini XXP-HP is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology. The Gemini XXP-HP is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm for Shockwave Treatment, Patient Table, Control Desk User Interface. The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-arm. The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete X-ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones. The Gemini XXP-HP's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures. The image processing system with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling. The Gemini XXP-HP also includes a camera to view in real time the integrity of the patient to bellows coupling interface.
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    K Number
    K142561
    Device Name
    LM-9300 ELMA Lithotripter
    Manufacturer
    LITE-MED INC.
    Date Cleared
    2015-03-20

    (190 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Why did this record match?
    Product Code :

    LNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lite-Med LM-9300 ELMA Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle and lower ureteral stones by extracorporeal shock wave lithotripsy (ESWL).
    Device Description
    The Lite-Med LM-9000 ELMA is an Electromagnetic Extracorporeal Shock Wave Lithotripter that effectively treats urinary calculi. It is routinely used for the fragmentation of kidney and ureteral stones and offers a good combination of clinical performance, flexibility and affordability. The standard LM-9300 ELMA system consists of a shockwave generator, an operator interface (industrial computer with dual monitors), a water circulation subsystem and a patient handling subsystem. For the Extracorporeal Shock Wave Lithotripsy (ESWL) operation to be fully functional, one or two more subsystems are necessary. The first is a C-arm X-ray fluoroscopy device and the second is an ultrasound imaging unit. Normally one of the imaging devices is sufficient. For most advanced ESWL designs such as LM-9300 ELMA both X-ray and ultrasound are used for patient positioning and monitoring purposes. Shock waves are generated on the basis of a principle similar to that used in loudspeakers. An electrical impulse is sent through an inductance coil, generating a magnetic field which repulses a metallic membrane. The acoustic impulse created by this repulsion is focused by an acoustic lens to form a shock wave. A water circulation subsystem is used to provide transmission of shockwaves and cooling of the generator.
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    K Number
    K131817
    Device Name
    EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
    Manufacturer
    OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD.
    Date Cleared
    2014-09-26

    (463 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Why did this record match?
    Product Code :

    LNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CS-2012A-3 is intended for use by attending physician in the treatment of all kinds of calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
    Device Description
    ESWL, model CS-2012A-3, is an mobile electromagnetic lithotripter with a focal zone to treat patients, the shock wave generator has a high voltage power supply, a closed circuit water supply system with a tank, an spherical concave electromagnetic coil, a membrane and a water cushion (rubber membrane) for the acoustic conductivity of the shock waves to the patient. It is intended to be used properly by trained and qualified medical personnel for use in noninvasive fragmentation of urinary calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter). The shock waves are generated by the high voltage discharge through the electromagnetic coil which repels the membrane creating a shockwave. The shockwave is then focused to the focal point. The stones to be fragmented are positioned at this focal point by moving the motorized patient table in 3 axis. The localization is performed with a separate and commercially available mobile fluoroscopic x-ray unit and/or US equipment. The device includes following parts: 1. ESWL device The ESWL device contains therapy head, main switch, control panel, target indicator and foot pedal. It also provides patient with treatment, controls functions of CS-2012A-3. 2. Therapy table Therapy table consists of table (For personal hygiene, the table should be covered by disposable medical nonwoven fabrics in treatment), table supporter and 3-dimension movement. Patient is positioned on therapy table. Table cutout area allows positioning of therapy table near patient, table can be moved as required. Table motion is completely independent of ESWL device. It has its own 3 dimension movement, not to link CS-2012A-3.
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