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3dscope

FDA UDI

Class II (US FDA UDI)

by Direx Systems Corp.

Identity

Trade Name
3DSCOPE FDA UDI
Generic Name
Fluoroscopic x-ray system video image recording unit FDA UDI
Device Name
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. FDA UDI
Model / Reference
3DSCOPE FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00863499000322 FDA UDI
FDA Product Code
JAA FDA UDI
GMDN Term
Fluoroscopic x-ray system video image recording unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Fluoroscopic x-ray system video image recording unit

3dscope by Direx Systems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluoroscopic x-ray system video image recording unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Direx Systems Corp.

Sources (1)

  • FDA UDI 07a4d84d-53df-405e-a006-1c1205d2ee21 33 fields · synced May 30, 2026