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510(k) Data Aggregation
K Number
K042561Device Name
TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Manufacturer
Date Cleared
2004-10-12
(21 days)
Product Code
Regulation Number
876.5990Why did this record match?
Applicant Name (Manufacturer) :
FMD, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Twinheads® TH-103 Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Device Description
The Twinheads® TH-103 ESWL is a spark gap dual head shock wave lithotripter for the fragmentation of kidney and ureteral calculi. The Twinheads® TH-103 delivers a pair of shock wayes, which are separated from each other by a certain delay time, with perpendicular trajectories and overlapping focal zones. The pulse pairs or twin shocks are aligned with the calculi or stone utilizing legally marketed C-arm fluoroscopy system via two orientations. Also included is an accurate motorized table with carbon fiber top.
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K Number
K030346Device Name
TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Manufacturer
Date Cleared
2003-05-02
(88 days)
Product Code
Regulation Number
876.5990Why did this record match?
Applicant Name (Manufacturer) :
FMD, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Device Description
The Twinheads® TH-101 ESWL is a spark gap dual head shock wave lithotripter with an integrated fluoroscopy system for the fragmentation of kidney and ureteral calculi. The Twinheads® TH-101 delivers a pair of shock waves, which are separated from each other by a certain delay time, with perpendicular trajectories and overlapping focal zones. The pulse pairs or twin shocks are aligned with the calculi or stone utilizing the fluoroscopy system via two orientations. A rapid current pulse discharges through a small gap in each of the two heads. The pulse discharge creates a shock wave, which radiates outward. Two identical ellipsoid reflectors serve to reflect and focus the shock waves, which are transmitted into the patient by a water cushion through a membrane and contact gel. There are two shockwave sources and two cushions in the Twinheads® TH-101 ESWL. Also included are an accurate motorized table and U-arm movements, high resolution fluoroscopy, and efficient shock wave energy sources.
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