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

Devices Manufactured by FUJIFILM CORPORATION

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• 04547410524284 - FUJIFILM: 2024-10-14 This product is intended to be used in combination with the compatible endoscopes, camera head, light source and light guide to
• 14547410500643 - FUJIFILM: 2024-09-30 FUJIFILM Endoscope Model EG-840N is intended for the visualization of the upper digestive tract, specifically for the observatio
• 04547410517330 - FUJIFILM: 2024-09-30 FUJIFILM Endoscope Model EG-840T, EG-840TP is intended for the visualization of the upper digestive tract, specifically for the
• 14547410528265 - FUJIFILM: 2024-09-30 FUJIFILM Endoscope Model EG-840T, EG-840TP is intended for the visualization of the upper digestive tract, specifically for the
• 04573596200704 - APERTO Lucent: 2024-09-27 Magnetic Resonance Diagnostic Device
• 04573596204368 - ECHELON Synergy: 2024-09-19Magnetic Resonance Diagnostic Device
• 04573596204368 - ECHELON Synergy: 2024-09-19 Magnetic Resonance Diagnostic Device
• 04547410530582 - DR-ID 1281SE: 2024-09-09 The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the d