| Primary Device ID | 00195278372307 |
| NIH Device Record Key | 5e9e6b3d-841a-480f-836b-b957746514f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | SIGNA Voyager AIR |
| Company DUNS | 421356265 |
| Company Name | GE Medical Systems (Tianjin) Co., Ltd. |
| 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 | false |
| 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 | 00195278372307 [Primary] |
| MOS | Coil, magnetic resonance, specialty |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-23 |
| Device Publish Date | 2021-06-15 |
| 00195278707871 - NA | 2024-02-13 SIGNA Champion System Medical Device |
| 00195278629234 - NA | 2023-08-14 SIGNA Voyager 1.5T Detachable Table - Wireless Gating |
| 00195278616845 - NA | 2023-03-20 SIGNA Victor System Medical Device |
| 00195278481382 - NA | 2022-09-16 SIGNA Artist Evo System Medical Device, MDR |
| 00840682146302 - NA | 2022-03-15 SIGNA Prime System Medical Device |
| 00195278372307 - NA | 2021-06-23Voyager AIR Medical Device Assembly |
| 00195278372307 - NA | 2021-06-23 Voyager AIR Medical Device Assembly |
| 00195278248923 - NA | 2021-05-04 SIGNA Voyager 1.5T Detachable Table Assembly |
| 00195278124609 - NA | 2021-02-10 Kizuna System Medical Device Assembly-MDR |