IMRIS iMRI 3T V

GUDID 00857534006745

IMRIS IMRI 3T V

DEERFIELD IMAGING, INC.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00857534006745
• NIH Device Record Key: 4031b1f9-377c-4f9a-a65d-1b124fa155b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMRIS iMRI 3T V
• Version Model Number: 120823-000
• Company DUNS: 079990922
• Company Name: DEERFIELD IMAGING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00857534006745 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212367

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: 2021-11-05
• Device Publish Date: 2021-10-28

Devices Manufactured by DEERFIELD IMAGING, INC.

• 00857534006837 - Horseshoe Headrest: 2024-11-11 Horseshoe Headrest Starter Kit, HFD 100
• 00857534006844 - Horseshoe Headrest: 2024-11-11 Horseshoe Headrest Starter Kit, HFD 200
• 00857534006271 - VISIUSeye: 2024-10-14 VISIUSeye - iMRI 1.5T E
• 00857534006295 - VISIUSeye: 2024-10-14 VISIUSeye - iMRI 3T V
• 00857534006301 - VISIUSeye: 2024-10-14 VISIUSeye - iCT 64
• 00857534006363 - VISIUSmatrix: 2024-10-14 Application Platform 2.4 NA
• 00857534006455 - MR/X-ray HFD (HFD 200): 2024-10-14 MR/X-ray Head Fixation Device (HFD 200)
• 00857534006585 - VISIUSeye: 2024-10-14 VISIUSeye, iMRI 3T V