Optima

GUDID 00840682145749

GE MEDICAL SYSTEMS, INC.

Mobile basic diagnostic x-ray system, digital

• Primary Device ID: 00840682145749
• NIH Device Record Key: ed8741b4-2925-4a8c-b260-e9743416c197
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optima
• Version Model Number: XR240amx HD Upgrade Gen2
• Company DUNS: 809785715
• Company Name: GE MEDICAL SYSTEMS, INC.
• 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	00840682145749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162990

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-23
• Device Publish Date: 2019-07-15

On-Brand Devices [Optima]

• 00840682145749: XR240amx HD Upgrade Gen2
• 00840682142168: XR646 HD Upgrade
• 00840682123686: XR240amx HD Upgrade
• 00840682122351: XR240amx
• 00840682115278: XR200amx
• 00840682115261: XR220amx
• 00195278840233: XR646HD UDI Label