The following data is part of a premarket notification filed by Beijing Infervision Technology Co.,ltd. with the FDA for Inferread Lung Ct.ai.
| Device ID | K192880 |
| 510k Number | K192880 |
| Device Name: | InferRead Lung CT.AI |
| Classification | Lung Computed Tomography System, Computer-aided Detection |
| Applicant | Beijing Infervision Technology Co.,Ltd. Haidian District Beijing, CN 100085 |
| Contact | Chao Tang |
| Correspondent | Matt Deng Mid-Link Consulting Co.,Ltd 1900 Market St. 8th Floor Philadelphia, PA 19103 |
| Product Code | OEB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-09 |
| Decision Date | 2020-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850003095004 | K192880 | 000 |