| Primary Device ID | 00840682145954 |
| NIH Device Record Key | a8c736c1-504d-4ce8-8d21-5380c5a5fa47 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | SIGNA PET MR SPiCE Workstation |
| Company DUNS | 160032025 |
| Company Name | GENERAL ELECTRIC COMPANY |
| 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 | 00840682145954 [Primary] |
| OUO | Tomographic imager combining emission computed tomography with nuclear magnetic resonance |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-30 |
| Device Publish Date | 2020-06-22 |
| 00195278729224 - NA | 2023-09-28 PETMR PGR Upgrade Kit, MP24 to MP30 |
| 00195278648877 - NA | 2023-09-27 SIGNA PETMR System Medical Device Assembly - MDR |
| 00195278596628 - NA | 2022-08-31 SIGNA Premier 3.0T Detachable Table Assembly- Wireless Gating |
| 00195278596642 - NA | 2022-08-31 SIGNA Hero 3T Detachable Table Assembly- Wireless Gating |
| 00195278486813 - NA | 2022-02-21 SIGNA Hero System Medical Device Assembly - MDR |
| 00195278472083 - NA | 2022-01-10 SIGNA Hero 3T Detachable Table Assembly |
| 00195278122643 - NA | 2021-05-18 1.5T Signa HDxt Upgrade Kit Medical Device, MDR |
| 00195278005502 - NA | 2020-08-24 |