Revolution

GUDID 00195278804990

Revolution UPG3 - Designated System Medical Device

GE MEDICAL SYSTEMS, INC.

Full-body CT system

• Primary Device ID: 00195278804990
• NIH Device Record Key: ab06f11f-f74b-469a-8ae9-048cf70ebfb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revolution
• Version Model Number: UPG 3
• Company DUNS: 809785715
• Company Name: GE MEDICAL SYSTEMS, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00195278804990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233750

FDA Product Code

• JAK: System, x-ray, tomography, computed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-23
• Device Publish Date: 2024-09-14

On-Brand Devices [Revolution]

• 00840682146616: Apex
• 00840682143646: CT with Apex edition
• 00840682140713: CT with Quantix Upgrade
• 00840682138796: 160mm Detector Upgrade
• 00840682125574: Discovery CT A
• 00840682123471: CT ES
• 00840682118552: CT
• 00840682102490: Discovery CT
• 00195278518866: Revolution CT Power - Designated System Medical Device
• 00195278804990: Revolution UPG3 - Designated System Medical Device