Revolution Apex B7919YO

GUDID 00195278788665

Revolution Apex Select with Plus Edition - Designated System Medical Device

Hangwei GE Medical Systems Co., Ltd.

Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system

• Primary Device ID: 00195278788665
• NIH Device Record Key: 87b44488-3474-4839-bdcb-b31d62c9a030
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revolution Apex
• Version Model Number: Select with Plus Edition
• Catalog Number: B7919YO
• 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: 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	00195278788665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213715

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: 2024-01-03
• Device Publish Date: 2023-12-26

Devices Manufactured by Hangwei GE Medical Systems Co., Ltd.

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• 00195278526892 - Definium: 2023-09-26 Definium Pace Select system designated medical device
• 00195278713759 - NA: 2023-09-26 Galaxy 2.0 Wall Stand
• 00195278713766 - NA: 2023-09-26 Value Fixed Table
• 00195278686718 - Revolution: 2023-06-30 Revolution Maxima CT designated medical device
• 00195278524904 - Optima: 2022-10-28 Optima IGS Ultra UDI
• 00195278524911 - Optima: 2022-10-28 Optima IGS Mega UDI