| Primary Device ID | 04987670105005 |
| NIH Device Record Key | 4c11c559-5b72-4183-914e-0a3f95a039fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vitrea Software Package |
| Version Model Number | VSTP-002A |
| 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 | 04987670105005 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-02 |
| Device Publish Date | 2023-04-24 |
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| 04987670100079 - CATHETERIZATION TABLE | 2025-03-21 |
| 04987670100345 - X-RAY FLAT PANEL DETECTOR | 2025-03-11 |
| 04987670104312 - X-RAY FLAT PANEL DETECTOR | 2025-03-11 |
| 04987670104121 - Aquilion Exceed LB | 2025-01-22 |
| 04987670105579 - Aquilion ONE | 2025-01-17 |
| 04987670104541 - DIAGNOSTIC ULTRASOUND SYSTEM | 2024-07-15 |