OPERA SWING

GUDID 08054890480048

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: 08054890480048
• NIH Device Record Key: c98ef80e-aa54-448e-9e5b-4d8a4abb91d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPERA SWING
• 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	08054890480048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140380

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: 4
• Public Version Date: 2019-04-10
• Device Publish Date: 2016-09-22

On-Brand Devices [OPERA SWING]

• 08054890480048: It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid sta
• 08054890480031: The device is a stretcher in carbon fiber and it is raised via an hydraulic piston mechanism whi
• 08054890480017: The device is a R&F remote tilting table which allows the execution of longitudinal, trasversal
• 08054890480000: The Opera Swing is an x-ray diagnostic system and is indicated for performing general radiograph