EndoScreener
Gastrointesinal Lesion Software Detection System
Chengdu Wision Medical Device Co., LTD.
The following data is part of a premarket notification filed by Chengdu Wision Medical Device Co., Ltd. with the FDA for Endoscreener.
Pre-market Notification Details
| Device ID | K211326 |
| 510k Number | K211326 |
| Device Name: | EndoScreener |
| Classification | Gastrointesinal Lesion Software Detection System |
| Applicant | Chengdu Wision Medical Device Co., LTD. Unit 802, Floor 8, Building 17, Yintaicheng, No. 1999 Yizhou Road, Wuhou District Chengdu, CN 610041 |
| Contact | Jingjia Liu |
| Correspondent | John J Smith Hogan Lovells US LLP 555 Thirteenth St, NW Washington, DC 20004 |
| Product Code | QNP |
| CFR Regulation Number | 876.1520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-30 |
| Decision Date | 2021-11-19 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973770840012 | K211326 | 000 |
Trademark Results [EndoScreener]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOSCREENER 88281425 not registered Live/Pending |
SHANGHAI WISION AI CO.,LTD. 2019-01-29 |
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