The following data is part of a premarket notification filed by Wuxi Hisky Medical Technologies Co., Ltd. with the FDA for Shear Wave Quantificational Ultrasound Diagnostic System.
| Device ID | K200136 |
| 510k Number | K200136 |
| Device Name: | Shear Wave Quantificational Ultrasound Diagnostic System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Wuxi Hisky Medical Technologies Co., Ltd. B401, 530 Plaza, University Science Park, Taihu International Science & Tech. Wuxi, CN 214135 |
| Contact | Jinhua Shao |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd 5-402, Building #27, No. 56, LiangXiang East Rd., FangShan District Beijing, CN 102401 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-21 |
| Decision Date | 2020-03-17 |