Imagio Breast Imaging System
Seno Medical Instruments, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014755924 | 3014755924 | SENO MEDICAL INSTRUMENTS, INC. | 1 | N | 2026-01-01 | 8023 Vantage Drive, Suite 1000 San Antonio TX US 78230 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00864802000442 | Imagio® - Transducer (OA/US Probe) Model 8100 | 888-978-8835 | service@senomedical.com |
| 00864802000459 | Imagio® - Imagio Breast Imaging System Model 9100 | 888-978-8835 | service@senomedical.com |
| 00864802000466 | Imagio® - US L18-5 Probe | 888-978-8835 | service@senomedical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 296679 | 1661801159 | P200003 | Imagio Breast Imaging System | QNK | 2021-01-11 |
| 296679 | 1203701636 | K191007 | Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems | IYN | 2019-10-25 |
| 296679 | 1469735321 | K182628 | Imagio Ultrasound Imaging System | IYN | 2019-03-05 |
Seno Medical Instruments, Inc.
Seno Medical Instruments, Inc.
2023-07-07
2023-07-07
2023-07-07