Revolution B7919QT-B7919QS

GUDID 00195278469700

Revolution Apex Select - Designated System Medical Device

Hangwei GE Medical Systems Co., Ltd.

Full-body CT system

• Primary Device ID: 00195278469700
• NIH Device Record Key: fa30517e-9a5e-44f5-aa29-966f6b32988c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revolution
• Version Model Number: Apex Select
• Catalog Number: B7919QT-B7919QS
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278469700 [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: 2022-02-14
• Device Publish Date: 2022-02-04

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