3DSCOPE - 3Dscope is intended for acquisition, processing - DIREX SYSTEMS CORP.

Duns Number:837501337

Device Description: 3Dscope is intended for acquisition, processing and display of fluoroscopy images.It can b 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.

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More Product Details

Catalog Number

-

Brand Name

3DSCOPE

Version/Model Number

3DSCOPE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JAA

Product Code Name

System, X-Ray, Fluoroscopic, Image-Intensified

Device Record Status

Public Device Record Key

07a4d84d-53df-405e-a006-1c1205d2ee21

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIREX SYSTEMS CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5