Revolution RevolutionMaxima

GUDID 00198953049174

Revolution Maxima CT designated medical device for Buc

Hangwei General Electric Medical System Co., Ltd.

Full-body CT system

• Primary Device ID: 00198953049174
• NIH Device Record Key: 107bda11-87dc-4b0b-95c5-4d9ed030086f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revolution
• Version Model Number: Maxima QF
• Catalog Number: RevolutionMaxima
• Company DUNS: 554408642
• Company Name: Hangwei General Electric Medical System 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: 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	00198953049174 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-27
• Device Publish Date: 2025-10-15