| Primary Device ID | 00857534006219 |
| NIH Device Record Key | dbd4c45e-672d-405f-a9b3-b4d6a178d039 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iCT |
| Version Model Number | iCT System |
| Company DUNS | 079990922 |
| Company Name | DEERFIELD IMAGING, INC. |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00857534006219 [Primary] |
| JAK | System, X-Ray, Tomography, Computed |
| 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 | 2016-09-01 |
| 00857534006806 - InVision™ 3T Operating Suite | 2024-04-01 |
| 00857534006813 - InVision™ 1.5T Operating Suite | 2024-04-01 |
| 00857534006820 - IMRISeye | 2024-04-01 |
| 00857534006769 - IMRISeye - InVision 1.5 Surgical Theatre | 2024-03-05 |
| 00857534006776 - InVision 1.5 Surgical Theatre | 2024-03-05 |
| 00857534006783 - Starter Kit, 1.5T Flex Coil | 2023-10-12 |
| 00857534006790 - Starter Kit, 3T Flex Coil | 2023-10-12 |
| 00857534006745 - IMRIS iMRI 3T V | 2021-11-05 IMRIS IMRI 3T V |