ECHELON Synergy ECHELON Synergy

GUDID 04573596204368

Magnetic Resonance Diagnostic Device

FUJIFILM CORPORATION

Full-body MRI system, superconducting magnet

• Primary Device ID: 04573596204368
• NIH Device Record Key: 4a3db54e-e5f6-4aa9-b447-0579e8ee5c07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECHELON Synergy
• Version Model Number: ECHELON Synergy
• Catalog Number: ECHELON Synergy
• Company DUNS: 713565195
• Company Name: FUJIFILM CORPORATION
• 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	04573596204368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233687

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: 2024-09-19
• Device Publish Date: 2024-09-11

On-Brand Devices [ECHELON Synergy]

• 04573596204368: Magnetic Resonance Diagnostic Device
• 04547410565195: Receiver Coil