COMPACT DUET

Primary DI

00863499000339

Brand

COMPACT DUET

Company

DIREX SYSTEMS CORP.

Model

COMPACT DUET

Device description

The Duet is indicated for use in the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).The Duet is a transportable Extracorporeal Shock Wave Lithotripsy device, which consists of Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and Computer Console. The Duet does not provide imaging or monitoring functions, but contain the necessary interfaces for fluoroscopy and ECG R Wave Synchronization. The Duet is small and Transportable and can be used in any room equipped with the proper anesthesia devices. Special electrodes placed within two reflectors generate high-energy sparks, which can be controlled within defined limits. The shock waves generated by the sparks are focused through water and through the body to converge on the calculus. The shock waves must be generated and transmitted through liquid to assure that sufficient energy is delivered to the stone. A series of the focused shock waves is used for the stone disintegration.

Published

2016-11-02

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information