| Primary Device ID | 00840682119658 |
| NIH Device Record Key | 87cb807f-e687-4a8c-ba21-5711eb8e7772 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5421698 |
| Company DUNS | 809785715 |
| Company Name | GE MEDICAL SYSTEMS, 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 | 00840682119658 [Primary] |
| IZL | System, x-ray, mobile |
| 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 | 2016-08-01 |
| 00195278792822 - Omni | 2024-04-19 OMNI GANTRY ELECTRONICS ASSY, MEA |
| 00195278798374 - AMX | 2024-02-01 AMX Navigate Upgrade Designated Medical Device Assembly |
| 00195278789365 - Critical Care Suite | 2023-10-27 Critical Care Suite 2.1, Designated Medical Device |
| 00195278584441 - Quality Care Suite | 2023-09-22 Quality Care Suite 2.0, Medical Device |
| 00195278629586 - Head Auto Views | 2023-09-04 Head Auto Views MD Application Container for Smart Subscription |
| 00195278630377 - Spectral Bone Marrow | 2023-09-04 Spectral Bone Marrow MD Application Container for Smart Subscription |
| 00195278630384 - Spectral Color Overlay | 2023-09-04 Spectral Color Overlay MD Application Container for Smart Subscription |
| 00195278518866 - Revolution | 2023-04-10 Revolution CT Power - Designated System Medical Device |