GUDID 00195278122643

1.5T Signa HDxt Upgrade Kit Medical Device, MDR

GENERAL ELECTRIC COMPANY

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• Primary Device ID: 00195278122643
• NIH Device Record Key: 6deec774-303a-4c73-b553-88a5da01687f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1.5T HD29
• Company DUNS: 160032025
• Company Name: GENERAL ELECTRIC COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00195278122643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121676

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-18
• Device Publish Date: 2021-05-10

Devices Manufactured by GENERAL ELECTRIC COMPANY

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• 00195278472083 - NA: 2022-01-10 SIGNA Hero 3T Detachable Table Assembly
• 00195278122643 - NA: 2021-05-181.5T Signa HDxt Upgrade Kit Medical Device, MDR
• 00195278122643 - NA: 2021-05-18 1.5T Signa HDxt Upgrade Kit Medical Device, MDR
• 00195278005502 - NA: 2020-08-24