The following data is part of a premarket notification filed by Terarecon, Inc with the FDA for Terarecon Neuro.
| Device ID | K220349 |
| 510k Number | K220349 |
| Device Name: | TeraRecon Neuro |
| Classification | System, Image Processing, Radiological |
| Applicant | TeraRecon, Inc 4309 Emperor Blvd. Durham, NC 27703 |
| Contact | Michael Sosebee |
| Correspondent | Michael Sosebee TeraRecon, Inc 4309 Emperor Blvd. Durham, NC 27703 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-07 |
| Decision Date | 2022-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| NEURO02 | K220349 | 000 |