The following data is part of a premarket notification filed by Seno Medical Instruments, Inc. with the FDA for Imagio Ultrasound Imaging System.
| Device ID | K182628 |
| 510k Number | K182628 |
| Device Name: | Imagio Ultrasound Imaging System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Seno Medical Instruments, Inc. 8023 Vantage Drive, Suite 1000 San Antonio, TX 78240 |
| Contact | Katherin Harris |
| Correspondent | Ann Waterhouse Seno Medical Instruments, Inc. 8023 Vantage Drive, Suite 1000 San Antonio, TX 78240 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-03-05 |