3DSCOPE

Primary DI
00863499000322
Brand
3DSCOPE
Company
DIREX SYSTEMS CORP.
Model
3DSCOPE
Device description
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.
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863499000322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863499000322008634990003228634990003220863499000322

GMDN Terms#

Term, Definition table
TermDefinition
Fluoroscopic x-ray system video image recording unitAn assembly of devices that are part of a fluoroscopic x-ray system and specifically designed to display x-ray images in real-time. It is often referred to as an x-ray imaging chain. It includes a video camera [charge-coupled device (CCD) or tube based], a video signal generator, and cabling used to convert the analogue image taken from the output raster of the x-ray image intensifier and to display it on one or more image display monitors [visual display unit (VDU)] for immediate viewing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
837501337
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863499000308DUET MAGNAMAGNA10-MGNA-0002016-10-28
00863499000315INTEGRAINTEGRA2016-11-01
00863499000339COMPACT DUET COMPACT DUET2016-11-02
00863499000346TRIPTER X-1 COMPACTCOMPACT2016-11-01

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