| Primary Device ID | 00857534006165 |
| NIH Device Record Key | a20d3718-831f-463e-9c1e-c83d767d1866 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iMRX System |
| Version Model Number | iMRX System AR-DR-OR |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00857534006165 [Primary] |
| LNH | System, Nuclear Magnetic Resonance Imaging |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-04 |
| 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 |