| Primary Device ID | 00884838128477 |
| NIH Device Record Key | 2cf06198-7afe-4f9a-9d7e-cb27597e4f2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ingenia, MR5300, MR7700, Achieva |
| Version Model Number | Ingenia Ambition S |
| Catalog Number | 782194 |
| Company DUNS | 413819707 |
| Company Name | Philips Medical Systems Nederland B.V. |
| 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 | 00884838128477 [Primary] |
| LNH | System, Nuclear Magnetic Resonance Imaging |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-15 |
| Device Publish Date | 2026-01-07 |
| 00884838128415 - Ingenia | 2026-01-15 BlueSeal SE |
| 00884838128422 - Ingenia | 2026-01-15 BlueSeal XE |
| 00884838128439 - Ingenia | 2026-01-15 MR 7700 |
| 00884838128446 - Ingenia | 2026-01-15 MR 5300 |
| 00884838128453 - Ingenia | 2026-01-15 Ingenia Elition S |
| 00884838128460 - Ingenia | 2026-01-15 Ingenia Elition X |
| 00884838128477 - Ingenia, MR5300, MR7700, Achieva | 2026-01-15Ingenia Ambition S |
| 00884838128477 - Ingenia, MR5300, MR7700, Achieva | 2026-01-15 Ingenia Ambition S |
| 00884838128484 - Ingenia 3.0T | 2026-01-15 Ingenia Ambition X |