Revolution RevolutionMaxima

GUDID 00195278923257

Revolution Maxima CT designated medical device

Hangwei GE Medical Systems Co., Ltd.

Full-body CT system

• Primary Device ID: 00195278923257
• NIH Device Record Key: 3b101530-df2e-4b59-97bf-b7d27abceb17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revolution
• Version Model Number: Maxima Q
• Catalog Number: RevolutionMaxima
• Company DUNS: 654659689
• Company Name: Hangwei GE Medical Systems Co., Ltd.
• 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	00195278923257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192686

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: 2025-03-13
• Device Publish Date: 2025-03-05

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