The following data is part of a premarket notification filed by Infervision Medical Technology Co., Ltd. with the FDA for Inferread Ct Stroke.ai.
| Device ID | K211179 |
| 510k Number | K211179 |
| Device Name: | InferRead CT Stroke.AI |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| Applicant | Infervision Medical Technology Co., Ltd. Room B401, 4th Floor, Building 1, No. 12 Shangdi Information Road, Haidian District Beijing, CN 100085 |
| Contact | Xiaoyan Fan |
| Correspondent | Matt Deng Infervision US Inc 1900 Market St Philadelphia, PA 19103 |
| Product Code | QAS |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-20 |
| Decision Date | 2021-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850003095011 | K211179 | 000 |