The following data is part of a premarket notification filed by Shenzhen Wisonic Medical Technology Co., Ltd. with the FDA for Paragon Xhd Diagnostic Ultrasound System.
| Device ID | K191347 |
| 510k Number | K191347 |
| Device Name: | Paragon XHD Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Wisonic Medical Technology Co., Ltd. 1st, 2nd & 5th Floor, No. 6 Building, Pingshan Tech Park, Taoyuan Street, Nanshan Shenzhen, CN 518055 |
| Contact | Jiang Xiaosan |
| Correspondent | Jiang Xiaosan Shenzhen Wisonic Medical Technology Co., Ltd. 1st, 2nd & 5th Floor, No. 6 Building, Pingshan Tech Park, Taoyuan Street, Nanshan Shenzhen, CN 518055 |
| 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 | 2019-05-20 |
| Decision Date | 2020-02-07 |