FDA.reportPublic FDA data

DIREX SYSTEMS CORP.

PMN#

PRONEX

2010-12-07

DIREX SYSTEMS CORP.

VERT-X

2006-08-18

DIREX SYSTEMS CORP.

MIGUE

2006-03-10

DIREX SYSTEMS CORP.

INTEGRA

2006-03-01

DIREX SYSTEMS CORP.

DART-12

2006-02-21

DIREX SYSTEMS CORP.

3DSCOPE

2004-07-22

Direx Systems Corp.

GUDID#

DUET MAGNA - Duet Magna is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and the upper ureter.The device incorporates two electromagnetic shockwaves transducers at complementary angles to the horizon. The transducers can be operated separately (Top/Bottom) or alternate.A series of focused shockwaves produced by electromagnetic transducers are coupled to a patient flank and are made to converge on urinary stones and disintegrate them. The patient is placed on a treatment table and x-ray and/or ultrasonic imaging device to localize the stone.The operator controls treatment parameters including shockwave intensity, pulse rate, the number of shocks and ECG Synchronization.

DIREX SYSTEMS CORP.

2016-10-28

INTEGRA - INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of the following:• UCON• Integrated unit, includes the following: Shock Wave Generator (SWAG) Fluoroscopy device (X-Ray Module) Patient TableThe SWAG includes a high voltage generator module, a Reflector module, and a water module, and is located under the patient table.The Reflector is mechanically coupled to an X-Ray Tube Monoblock. The Reflector/ Monoblock assembly is attached via a U-arm to an Image Intensifier and a digital camera Module, for real time stone imaging.The U-Arm assembly is motorized, such that all three modules (Reflector, Monoblock, and Image Intensifier) move simultaneously as one piece and can be displaced electrically in all three axes, thus enabling the stone to be lined up in the therapeutic focal point.The patient and table do not move. The patient lies still on the table and only the U-Arm Assembly moves until the stone is localized.The UCON enables control over all operational aspects of the integrated unit via a software application.The operator chooses the various parameters to control the treatment including the number of shocks, intensity, frequency, etc.INTEGRA contains the necessary interfaces for ECG synchronization and ultrasonic imaging devices. INTEGRA can be used in any room equipped with the proper anesthesia equipment.

DIREX SYSTEMS CORP.

2016-11-01

3DSCOPE - 3Dscope is intended for acquisition, processing and display of fluoroscopy images.It can be also used together with an extra-corporeal shockwave lithotripsy. 3Dscope enables:• Visualization of various objects on fluoroscopy images (for example, kidney stones).• Generation and storage of patient records.• Comparing images obtained at different times. • Generation and management of patient data files and fluoroscopy images.The device is composed of the following units:• Workstation Console, which contains the application software for the system indicators and image display of the following: System status  Fluoroscopy images• Gantry unit, which contains he HF X-Ray generator, image intensifier and digital camera. It performs the following: Generator control  Image initial processing Data transfer to the Workstation console.

DIREX SYSTEMS CORP.

2016-11-01

COMPACT DUET - 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.

DIREX SYSTEMS CORP.

2016-11-02