The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Neuro.al Algorithm.
| Device ID | K200750 |
| 510k Number | K200750 |
| Device Name: | Neuro.Al Algorithm |
| Classification | System, Image Processing, Radiological |
| Applicant | TeraRecon, Inc. 4309 Emperor Blvd., Suite 310 Durham, NC 27703 |
| Contact | Megha Jain |
| Correspondent | Patrick Willhite TeraRecon, Inc. 4309 Emperor Blvd., Suite 310 Durham, NC 27703 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-23 |
| Decision Date | 2020-11-06 |