Not Applicable

GUDID 00840682115971

GENERAL ELECTRIC COMPANY

Full-body MRI system, superconducting magnet

• Primary Device ID: 00840682115971
• NIH Device Record Key: 5e5879af-5f6e-4589-82c5-9acfac7756af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Not Applicable
• Version Model Number: Optima MR450w 1.5T
• Company DUNS: 160032025
• Company Name: GENERAL ELECTRIC COMPANY
• 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	00840682115971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142085

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

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: 2016-08-01

On-Brand Devices [Not Applicable]

• 00840682105613: 5265300-50
• 00840682115971: Optima MR450w 1.5T
• 00840682115872: Discovery MR750 3.0T
• 00840682105699: 5494440