Revolution

GUDID 00840682140713

GE MEDICAL SYSTEMS, INC.

Full-body CT system

• Primary Device ID: 00840682140713
• NIH Device Record Key: 217c09ec-c287-46eb-ad76-040eab37d07f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revolution
• Version Model Number: CT with Quantix Upgrade
• 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: 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	00840682140713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133705

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-17

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