The following data is part of a premarket notification filed by Hangzhou Deepwise & League Of Phd Technology Co.,ltd. with the FDA for Medical Image Processing Software.
| Device ID | K220910 |
| 510k Number | K220910 |
| Device Name: | Medical Image Processing Software |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Hangzhou Deepwise & League Of PHD Technology Co.,Ltd. Room 705, Building 8, 1818-2 Wenyi West Road, Yuhang District Hangzhou, CN 311121 |
| Contact | Hailong Xu |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-29 |
| Decision Date | 2022-08-11 |