Revolution CT 5826588-X

GUDID 00195278471277

Revolution CT ES with Apex edition - Designated System Medical Device

GE Medical Systems, L.L.C.

Full-body CT system

• Primary Device ID: 00195278471277
• NIH Device Record Key: 3152e434-5f60-423b-9bc4-1899c26caf4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revolution CT
• Version Model Number: ES with Apex edition
• Catalog Number: 5826588-X
• Company DUNS: 144879404
• Company Name: GE Medical Systems, L.L.C.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278471277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191777

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: 2026-02-11
• Device Publish Date: 2022-12-16

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• 00195278471277 - Revolution CT: 2026-02-11Revolution CT ES with Apex edition - Designated System Medical Device
• 00195278471277 - Revolution CT: 2026-02-11 Revolution CT ES with Apex edition - Designated System Medical Device
• 00195278502179 - Revolution: 2026-02-11 Revolution Apex Plus - Designated System Medical Device