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

• Primary Device ID: 08054890480079
• NIH Device Record Key: f2fa82e9-f9fe-4aa0-a2da-57b9e38719e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLISIS SYSTEMS
• Version Model Number: OPERA D4000RF
• Company DUNS: 428658934
• Company Name: GENERAL MEDICAL MERATE SPA
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054890480079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173395
• Premarket Notification: K213081

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: 2019-04-10
• Device Publish Date: 2018-07-11

On-Brand Devices [CLISIS SYSTEMS]

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