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510(k) Data Aggregation
K Number
K063504Device Name
ECONOLITH EM1000
Manufacturer
MEDISPEC, LTD.
Date Cleared
2007-03-09
(109 days)
Product Code
LNS
Regulation Number
876.5990Why 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
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K Number
K040461Device Name
ECONOLITH E3000, MODEL 3000 (SW-6)
Manufacturer
MEDISPEC, LTD.
Date Cleared
2004-05-25
(92 days)
Product Code
LNS
Regulation Number
876.5990Why 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.
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K Number
K974796Device Name
LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER
Manufacturer
MEDISPEC, LTD.
Date Cleared
1998-03-12
(80 days)
Product Code
FFK
Regulation Number
876.4480Why 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.
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