Discovery

GUDID 00840682118699

Hangwei GE Medical Systems Co., Ltd.

Full-body CT system

• Primary Device ID: 00840682118699
• NIH Device Record Key: 6053ba52-52a7-49a5-b3d6-cf8c7b5e4a16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Discovery
• Version Model Number: RT
• 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	00840682118699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093581

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-24

On-Brand Devices [Discovery]

• 00840682146210: XR656
• 00840682138598: XR656 HD
• 00840682118699: RT
• 00840682115322: XR656