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510(k) Data Aggregation
K Number
K130729Device Name
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
Manufacturer
Date Cleared
2013-05-14
(57 days)
Product Code
Regulation Number
876.5990Why did this record match?
Applicant Name (Manufacturer) :
DORNIER MEDTECH SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Gemini FPD 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 FPD is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology.
The Gemini FPD 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; and .
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. the FPD image receptor module, and a high resolution camera 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 FPD'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. It is the same as in the predicate device.
The image processing system with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.
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