MRopen EVO

GUDID B5450320000080

MROpen EVO 03-2000-00 v8 Whole body magnetic resonance diagnostic medical device intended for the production of images for diagnostic purposes with transverse, coronal, sagittal and oblique orientation relating to the internal structures of the examined body areas, also including the examination of the brain through the DWI sequence, with limitations regarding cardiac, breast, lung and upper abdominal imaging.

ASG SUPERCONDUCTORS SPA

Full-body MRI system, superconducting magnet

• Primary Device ID: B5450320000080
• NIH Device Record Key: 42c02bed-f7f3-43f6-aa5b-d8d67c87042e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRopen EVO
• Version Model Number: 03-2000-00 v8
• 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	B5450320000080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242258

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: 2024-12-26
• Device Publish Date: 2024-12-18

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