Discovery

GUDID 00840682115322

Hangwei GE Medical Systems Co., Ltd.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00840682115322
• NIH Device Record Key: 76bc80c3-dc51-4f0b-8c6a-b76466f66bfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Discovery
• Version Model Number: XR656
• 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	00840682115322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132261

FDA Product Code

• IZF: System, x-ray, tomographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-05
• Device Publish Date: 2016-05-26

On-Brand Devices [Discovery]

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