iMRI 1.5T A

GUDID 00857534006097

IMRIS SAE OR-DR Partial Body Imaging, 116115-000

DEERFIELD IMAGING, INC.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00857534006097
• NIH Device Record Key: 89481bf6-1a89-493c-b152-53c66104fe98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iMRI 1.5T A
• Version Model Number: iMRI 1.5T A, OR-DR
• 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	00857534006097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133692

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [iMRI 1.5T A]

• 00857534006103: IMRIS SAE OR-DR-OR Full Body Imaging, 116116-000
• 00857534006097: IMRIS SAE OR-DR Partial Body Imaging, 116115-000
• 00857534006080: IMRIS SAE OR-DR-OR Full Body Imaging, 116114-000
• 00857534006073: IMRIS SAE OR-DR-OR Partial Body Imaging, 116113-000