NEONA 1.5T MRI System

GUDID 00862694000328

TIME MEDICAL SYSTEMS

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• Primary Device ID: 00862694000328
• NIH Device Record Key: 854b1ee2-edf0-41ed-9a1b-37547392b18f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEONA 1.5T MRI System
• Version Model Number: 15000-02
• Company DUNS: 020884437
• Company Name: TIME MEDICAL SYSTEMS
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862694000328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222259

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: 2023-03-30
• Device Publish Date: 2023-03-22

Devices Manufactured by TIME MEDICAL SYSTEMS

• 00862694000328 - NEONA 1.5T MRI System: 2023-03-30
• 00862694000328 - NEONA 1.5T MRI System: 2023-03-30
• 00862694000311 - EMMA 1.5T MRI System: 2023-03-24
• 00862694000304 - PICA Whole-body MRI System: 2018-07-06