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 |