| Primary Device ID | 00195278584441 |
| NIH Device Record Key | 84b35f44-dffa-4992-9c34-e9f6704ba43f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quality Care Suite |
| Version Model Number | 2.0 |
| Catalog Number | 5833126 |
| Company DUNS | 809785715 |
| Company Name | GE MEDICAL SYSTEMS, INC. |
| 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 | true |
| Serial Number | false |
| 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 | 00195278584441 [Primary] |
| LHO | Instrument, quality-assurance, radiologic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-22 |
| Device Publish Date | 2023-01-24 |
| 00195278560384 - Auto Segmentation | 2024-11-13 MD Auto Segmentation for Smart Subscription |
| 00195278865335 - SnapShot Freeze 2 | 2024-10-21 SnapShot Freeze Medical Device |
| 00195278804990 - Revolution | 2024-09-23 Revolution UPG3 - Designated System Medical Device |
| 00195278901439 - Omni | 2024-09-23 OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY - WSO |
| 00195278454218 - Omni | 2024-08-15 OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY |
| 00195278840226 - Discovery | 2024-07-12 XR656HD UDI Label |
| 00195278840233 - Optima | 2024-07-12 XR646HD UDI Label |
| 00195278792822 - Omni | 2024-04-19 OMNI GANTRY ELECTRONICS ASSY, MEA |