The following data is part of a premarket notification filed by Cleerly, Inc. with the FDA for Cleerly Labs V2.0.
| Device ID | K202280 |
| 510k Number | K202280 |
| Device Name: | Cleerly Labs V2.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Cleerly, Inc. 101 Greenwich St, Suite 11C New York, NY 10006 |
| Contact | James K. Min |
| Correspondent | John Smith Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-11 |
| Decision Date | 2020-10-02 |