| Primary Device ID | 04987670104374 |
| NIH Device Record Key | 1d7f2339-833e-4c03-9a90-ead450d00de7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ULTRASOUND IMAGE ANALYSIS PROGRAM UltraExtend NX CUW-U001S |
| Version Model Number | CUW-U001S |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987670104374 [Primary] |
| QIH | Automated Radiological Image Processing Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-10 |
| Device Publish Date | 2025-07-02 |
| 04987670104374 - ULTRASOUND IMAGE ANALYSIS PROGRAM UltraExtend NX CUW-U001S | 2025-07-10 |
| 04987670104374 - ULTRASOUND IMAGE ANALYSIS PROGRAM UltraExtend NX CUW-U001S | 2025-07-10 |
| 04987670103216 - CONVEX ARRAY TRANSDUCER | 2025-04-09 |
| 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 |