| Primary Device ID | 04987670105579 |
| NIH Device Record Key | 34013e59-fffc-42aa-842e-f833886d12ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aquilion ONE |
| Version Model Number | TSX-308A |
| Company DUNS | 690575113 |
| Company Name | CANON MEDICAL SYSTEMS CORPORATION |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987670105579 [Primary] |
| JAK | System, X-Ray, Tomography, Computed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-17 |
| Device Publish Date | 2025-01-09 |
| 04987670104121 - Aquilion Exceed LB | 2025-01-22 |
| 04987670105579 - Aquilion ONE | 2025-01-17 |
| 04987670105579 - Aquilion ONE | 2025-01-17 |
| 04987670104541 - DIAGNOSTIC ULTRASOUND SYSTEM | 2024-07-15 |
| 04987670104558 - DIAGNOSTIC ULTRASOUND SYSTEM | 2024-07-15 |
| 04987670106095 - Aquilion Serve SP | 2024-07-12 |
| 04987670100925 - BIOPSY ADAPTOR | 2024-04-22 |
| 04987670104626 - LINEAR ARRAY TRANSDUCER | 2024-04-22 |
| 04987670104633 - LINEAR ARRAY TRANSDUCER | 2024-04-22 |