GUDID 00195278010797

GENERAL ELECTRIC COMPANY

Full-body MRI system, superconducting magnet

• Primary Device ID: 00195278010797
• NIH Device Record Key: 332dd2de-774f-4fc4-b60d-ce7b39ab6ecc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SIGNA Premier
• 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	00195278010797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193282

FDA Product Code

• MOS: Coil, magnetic resonance, specialty

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: 2020-08-24
• Device Publish Date: 2020-08-14

Devices Manufactured by GENERAL ELECTRIC COMPANY

• 00195278729224 - NA: 2023-09-28 PETMR PGR Upgrade Kit, MP24 to MP30
• 00195278648877 - NA: 2023-09-27 SIGNA PETMR System Medical Device Assembly - MDR
• 00195278596628 - NA: 2022-08-31 SIGNA Premier 3.0T Detachable Table Assembly- Wireless Gating
• 00195278596642 - NA: 2022-08-31 SIGNA Hero 3T Detachable Table Assembly- Wireless Gating
• 00195278486813 - NA: 2022-02-21 SIGNA Hero System Medical Device Assembly - MDR
• 00195278472083 - NA: 2022-01-10 SIGNA Hero 3T Detachable Table Assembly
• 00195278122643 - NA: 2021-05-18 1.5T Signa HDxt Upgrade Kit Medical Device, MDR
• 00195278005502 - NA: 2020-08-24