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510(k) Data Aggregation
K Number
K062081Device Name
LITHOGOLD
Manufacturer
TISSUE REGENERATION TECHNOLOGIES, INC.
Date Cleared
2006-11-02
(104 days)
Product Code
LNS
Regulation Number
876.5990Why did this record match?
Applicant Name (Manufacturer) :
TISSUE REGENERATION TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).
Device Description
The LithoGold is an extracorporeal shock wave therapy device designed for the non-invasive fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle and lower ureter). The LithoGold employs an electrohydraulic method of shock wave generation with both ECG gating and fixed frequency capabilities. The LithoGold unit will be combined with the Modularis Uro Plus (table) and Arcadis NUW -- 2 2005 Varic (C-arm) or Siremobil Compact L (C-arm), all products manufactured by Siemens Medical Solutions, Inc .; and the ECG Monitor Infinity Gamma (ECG) manufactured by Draeger Medical systems, Inc. These components have each been cleared for distribution in the U.S.
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