The following data is part of a premarket notification filed by Imsonic Medical China, Inc. with the FDA for Imsonic Tr-1 Ultrasonic Pulsed Doppler Imaging System.
| Device ID | K220983 |
| 510k Number | K220983 |
| Device Name: | ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ImSonic Medical China, INC. No. 168 Yuanfeng Road Kunshan, CN 215300 |
| Contact | Xiaohui Hao |
| Correspondent | Xiaohui Hao ImSonic Medical China, INC. No. 168 Yuanfeng Road Kunshan, CN 215300 |
| 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 | 2022-04-04 |
| Decision Date | 2022-11-11 |