CLISIS SYSTEMS

GUDID 08054890480079

It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid state large-sized detector, specifically designed to be integrated in radiology diagnostic rooms and emergency rooms. Opera D4000RF alllows radiological diagnostic examinations to be performed in real time on the skeleton, the gastro-intestinal tract, the vascular system and urogenital system.

GENERAL MEDICAL MERATE SPA

Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital
Primary Device ID08054890480079
NIH Device Record Keyf2fa82e9-f9fe-4aa0-a2da-57b9e38719e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCLISIS SYSTEMS
Version Model NumberOPERA D4000RF
Company DUNS428658934
Company NameGENERAL MEDICAL MERATE SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108054890480079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-10
Device Publish Date2018-07-11

On-Brand Devices [CLISIS SYSTEMS]

08054890480093The ceiling suspension is a radiographic X-ray tube suspension device that allows direct digital
08054890480086The wall bucky stand is used to perform exposures on the potter-bucky.
08054890480079It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid sta
08054890480062It is an R&F remote controlled table, that can be used as a traditional R&F remote tilting table
08054890480055CLISIS SYSTEMS is a system indicated for performing general radiography, fluoroscopy and angiogr

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