| Primary Device ID | 00195278794772 |
| NIH Device Record Key | 8eae6ac6-a7b8-45aa-82ed-3eee2973ec5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | D630 to D670 DR Upgrade |
| Version Model Number | H3101RS |
| Catalog Number | 5953035 |
| Company DUNS | 532102365 |
| Company Name | G E MEDICAL SYSTEMS ISRAEL LTD. |
| 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 | false |
| 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 | 00195278794772 [Primary] |
| JAK | System, x-ray, tomography, computed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-26 |
| Device Publish Date | 2024-03-18 |
| 00198953061329 - NMCT 860 | 2025-09-17 NM_CT 860 NM Gantry Final MDR |
| 00198953061336 - NMCT 850 | 2025-09-17 NM_CT 850 NM Gantry Final MDR |
| 00195278878502 - Aurora | 2025-03-05 AURORA NM GANTRY FINAL |
| 00195278870490 - StarGuide MDD to MDR Upgrade | 2024-05-24 StarGuide SW and Labels Upgrade |
| 00195278755544 - StarGuide | 2024-04-26 StarGuide NM GANTRY MDR FINAL |
| 00195278794772 - D630 to D670 DR Upgrade | 2024-03-26D630 to D670 DR NM GANTRY UPGRADE KIT |
| 00195278794772 - D630 to D670 DR Upgrade | 2024-03-26 D630 to D670 DR NM GANTRY UPGRADE KIT |
| 00195278788252 - NM | 2023-11-23 830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE |
| 00195278788269 - NMCT | 2023-11-22 870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE |