The following data is part of a premarket notification filed by Densitas, Inc. with the FDA for Densitas Densityai.
| Device ID | K192973 |
| 510k Number | K192973 |
| Device Name: | Densitas Densityai |
| Classification | System, Image Processing, Radiological |
| Applicant | Densitas, Inc. #66, 1344 Summer Street Halifax, CA B3h0a8 |
| Contact | Mo Abdolell |
| Correspondent | Alex Morris Densitas Inc. #66, 1344 Summer Street Halifax, CA B3h0a8 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-24 |
| Decision Date | 2020-02-19 |