Optima

GUDID 00840682115339

Hangwei GE Medical Systems Co., Ltd.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00840682115339
• NIH Device Record Key: 4ca97eb0-27e6-42a7-a9e3-bcf36ce81c62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optima
• Version Model Number: XR646
• 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	00840682115339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143270

FDA Product Code

• MQB: Solid state x-ray imager (flat panel/digital imager)

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: 2016-06-01

On-Brand Devices [Optima]

• 00840682146937: CT680 Expert
• 00840682147415: Advance
• 00840682142175: XR646 HD
• 00840682138963: CT540 N
• 00840682118002: IGS 330 001
• 00840682117975: IGS 320 001
• 00840682115339: XR646
• 00840682102568: CT520
• 00840682102551: CT540
• 00195278524911: Optima IGS Mega UDI
• 00195278524904: Optima IGS Ultra UDI