Omni

GUDID 00195278792822

OMNI GANTRY ELECTRONICS ASSY, MEA

GE MEDICAL SYSTEMS, INC.

Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system

• Primary Device ID: 00195278792822
• NIH Device Record Key: 66c5179d-f2fa-44ab-bcf4-c4f5203954f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni
• Version Model Number: Legend
• 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	00195278792822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221932

FDA Product Code

• KPS: System, tomography, computed, emission

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: 2024-04-19
• Device Publish Date: 2024-04-11

Devices Manufactured by GE MEDICAL SYSTEMS, INC.

• 00195278792822 - Omni: 2024-04-19OMNI GANTRY ELECTRONICS ASSY, MEA
• 00195278792822 - Omni: 2024-04-19 OMNI GANTRY ELECTRONICS ASSY, MEA
• 00195278798374 - AMX: 2024-02-01 AMX Navigate Upgrade Designated Medical Device Assembly
• 00195278789365 - Critical Care Suite: 2023-10-27 Critical Care Suite 2.1, Designated Medical Device
• 00195278584441 - Quality Care Suite: 2023-09-22 Quality Care Suite 2.0, Medical Device
• 00195278629586 - Head Auto Views: 2023-09-04 Head Auto Views MD Application Container for Smart Subscription
• 00195278630377 - Spectral Bone Marrow: 2023-09-04 Spectral Bone Marrow MD Application Container for Smart Subscription
• 00195278630384 - Spectral Color Overlay: 2023-09-04 Spectral Color Overlay MD Application Container for Smart Subscription
• 00195278518866 - Revolution: 2023-04-10 Revolution CT Power - Designated System Medical Device