3DSCOPE

GUDID 00863499000322

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.

Fluoroscopic x-ray system video image recording unit

• Primary Device ID: 00863499000322
• NIH Device Record Key: 07a4d84d-53df-405e-a006-1c1205d2ee21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3DSCOPE
• Version Model Number: 3DSCOPE
• Company DUNS: 837501337
• Company Name: DIREX SYSTEMS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863499000322 [Primary]

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-01

Devices Manufactured by DIREX SYSTEMS CORP.

• 00863499000308 - DUET MAGNA: 2018-03-29 Duet Magna is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and the upper ureter. The devic
• 00863499000315 - INTEGRA: 2018-03-29 INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment.
• 00863499000322 - 3DSCOPE: 2018-03-293Dscope 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.
• 00863499000322 - 3DSCOPE: 2018-03-29 3Dscope is intended for acquisition, processing and display of fluoroscopy images. It can be also used together with an extra-co
• 00863499000339 - COMPACT DUET: 2018-03-29 The Duet is indicated for use in the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper uretera
• 00863499000346 - TRIPTER X-1 COMPACT: 2018-03-29 The Compact is intended for breaking apart urinary tract stones, e.g., renal calyceal, renal pelvic, and ureteral stones. The pu