| Primary Device ID | 00840682103572 |
| NIH Device Record Key | 56d1e458-5eb8-4bb8-b91c-5be58cb0293a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5121647-4 |
| Company DUNS | 654659689 |
| Company Name | Hangwei GE Medical Systems Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 00840682103572 [Primary] |
| IZZ | Table, radiographic, non-tilting, powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-07-17 |
| 00198953049631 - Revolution | 2025-09-17 Revolution Maxima CT designated medical device for India, without SGB Tube |
| 00195278943934 - Revolution | 2025-09-01 Revolution Vibe - Designated System Medical Device |
| 00195278907202 - Revolution | 2025-04-08 Revolution RT Gantry designated Medical Device, WSO |
| 00195278923257 - Revolution | 2025-03-13 Revolution Maxima CT designated medical device |
| 00195278940292 - Revolution | 2025-03-10 Revolution Maxima CT designated medical device, WSO make |
| 00195278685001 - OEC | 2025-01-17 MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One ASD |
| 00195278809810 - Revolution | 2025-01-03 Revolution RT Gantry designated Medical Device, GEHW |
| 00195278913807 - Definium | 2024-11-07 Definium Pace Select ET System UDI |