MRopen EVO

GUDID B5450320000040

ASG SUPERCONDUCTORS SPA

Full-body MRI system, superconducting magnet

• Primary Device ID: B5450320000040
• NIH Device Record Key: 4b2c2853-585f-4a95-a4d1-18cfbf3c7d7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRopen EVO
• Version Model Number: 03-2000-00 v.4
• Company DUNS: 438236494
• Company Name: ASG SUPERCONDUCTORS SPA
• 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
HIBCC	B5450320000040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193116

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: 2023-12-25
• Device Publish Date: 2023-12-15

On-Brand Devices [MRopen EVO]

• B5450320000040: 03-2000-00 v.4
• B5450320000080: MROpen EVO 03-2000-00 v8 Whole body magnetic resonance diagnostic medical device intended for th
• B54503200000120: MROpen EVO 03-2000-00 v12 Whole body magnetic resonance diagnostic medical device intended for t