Revolution

GUDID 00195278385215

Revolution Advance designated medical device

Hangwei GE Medical Systems Co., Ltd.

Full-body CT system

• Primary Device ID: 00195278385215
• NIH Device Record Key: d4013358-0726-4760-b979-da5b74594aa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revolution
• Version Model Number: Advance
• Company DUNS: 654659689
• Company Name: Hangwei GE Medical Systems Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	00195278385215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123596

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: 2021-06-21
• Device Publish Date: 2021-06-11

On-Brand Devices [Revolution]

• 00840682146180: Maxima
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• 00840682146197: ACT LMB
• 00840682137553: Frontier
• 00840682135313: ACT
• 00840682147392: Revolution Maxima CT designated medical device, WSO make
• 00195278403087: Revolution Eagle designated medical device
• 00195278385215: Revolution Advance designated medical device
• 00195278469700: Revolution Apex Select - Designated System Medical Device
• 00195278362247: Revolution Frontier ES for EOL CT Designated medical device
• 00195278362230: Revolution Frontier for EOL CT Designated medical device
• 00195278686718: Revolution Maxima CT designated medical device
• 00195278798107: Revolution Ascend Sliding designated medical device