Extracorporeal Shock Wave Lithotripter
Shenzhen Wikkon Precision Technologies Co., Ltd. · Model U200 · UDI-DI 06974928350131
Description
U200 ESWL system focuses shock waves into the body using ultrasound guidance to fragment urinary calculi (i.e kidney and ureteral stones). U200 system incorporates a shock wave generator, high voltage generator, control console, ultrasound system and patient table. Prior to treatment, the stone is targeted using a stand-alone ultra-sound system. Shock waves are typically generated using electromagnetically repelled membranes. These shock waves are focused onto the stone with specially designed acoustic lens. The shock waves are created under water by the shock wave generator, and are transferred to the patient’s body through a water-filled silicon cushion. Once the stone is fragmented by the focused shock waves, the fragments pass out of the body with the patient’s urine. U200 system is available in stationary configuration, and are indicated for use in a single health care facility
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-09-24 | Siemens Medical Solutions USA, Inc | Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs