The following data is part of a premarket notification filed by Deeplook Inc. with the FDA for Deeplook Precise.
| Device ID | K202084 |
| 510k Number | K202084 |
| Device Name: | DeepLook PRECISE |
| Classification | System, Image Processing, Radiological |
| Applicant | DeepLook Inc. 1220 Burton Street Silver Spring, MD 20910 |
| Contact | Steven Schwadron |
| Correspondent | Carl Alletto OTech Inc 8317 Belew Drive Mckinney, TX 75071 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-27 |
| Decision Date | 2021-04-09 |