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510(k) Data Aggregation
K Number
K072538Device Name
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER
Manufacturer
Date Cleared
2008-01-30
(145 days)
Product Code
Regulation Number
876.5990Why did this record match?
Applicant Name (Manufacturer) :
UNITED MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Piezolith 3000 Triple-Focus is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Device Description
The Piezolith 3000 Triple Focus consists of (1) a shock wave generator, which includes an adjustable therapy head/coupling mechanism mounted on an articulating arm or (when X·ray imaging is used) mounted to a swivel slide on C-arm (LITHOARM); (2) a control console (device trolley); (3) ultrasound imaging system for localization; (4) an optional X-ray system for localization; and (5) a treatment table.
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K Number
K032958Device Name
PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
Manufacturer
Date Cleared
2004-02-17
(148 days)
Product Code
Regulation Number
876.5990Why did this record match?
Applicant Name (Manufacturer) :
UNITED MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Piezolith 3000 is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Device Description
The Piezolith 3000 is comprised of the following principal components: (1) a shock wave generator, which includes an adjustable therapy head/coupling mechanism mounted on an articulating arm or (when X-ray imaging is used) mounted to a swivel slide on C-arm; (2) a control console; (3) an X-ray; (4) ultrasound imaging system for localization; and (5) a treatment table.
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