iMRX System

GUDID 00857534006158

iMRX System Post Assy, 1.5T 16CH Cardiac Coil,105856-000

DEERFIELD IMAGING, INC.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00857534006158
• NIH Device Record Key: 0dcb9e4e-ecaa-4e20-bf31-33375e90ef08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iMRX System
• Version Model Number: Post Assy, 1.5T 16CH Cardiac Coil
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857534006158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101813

FDA Product Code

• IZI: System, X-Ray, Angiographic

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: 2016-11-04

On-Brand Devices [iMRX System]

• 00857534006189: iMRX System AR-DR MR30RS,105824-000
• 00857534006172: iMRX System AR-DR-AR, MR30R, 105826-000
• 00857534006165: iMRX System AR-DR-OR, MR30R, 105828-000
• 00857534006158: iMRX System Post Assy, 1.5T 16CH Cardiac Coil,105856-000
• 00857534006141: iMRX System ANTERIOR ASSY, 3T 16CH CARDIAC COIL, 105587-000
• 00857534006127: iMRX System POSTERIOR ASSY, 3T 16CH CARDIAC COIL, 105589-000
• 00857534006110: iMRX System Ant Assy, 1.5T 16CH Cardiac Coil, 105855-000