| Primary Device ID | 00195278363947 |
| NIH Device Record Key | 3b2f2f3c-b7e4-49d1-bbf4-5fd3a9cc1882 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MaxFOV 2 |
| Version Model Number | 1.0 |
| Company DUNS | 654659689 |
| Company Name | Hangwei GE Medical Systems Co., 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 | 00195278363947 [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 | 2021-09-22 |
| Device Publish Date | 2021-09-14 |
| 00195278913807 - Definium | 2024-11-07 Definium Pace Select ET System UDI |
| 00195278832252 - NA | 2024-07-09 Galaxy 2.0 Wall Stand(Insert Left) |
| 00195278798107 - Revolution | 2024-03-07 Revolution Ascend Sliding designated medical device |
| 00195278788665 - Revolution Apex | 2024-01-03 Revolution Apex Select with Plus Edition - Designated System Medical Device |
| 00195278526892 - Definium | 2023-09-26 Definium Pace Select system designated medical device |
| 00195278713759 - NA | 2023-09-26 Galaxy 2.0 Wall Stand |
| 00195278713766 - NA | 2023-09-26 Value Fixed Table |
| 00195278686718 - Revolution | 2023-06-30 Revolution Maxima CT designated medical device |