The following data is part of a premarket notification filed by Cortechs Labs, Inc with the FDA for Onq Neuro.
| Device ID | K210831 |
| 510k Number | K210831 |
| Device Name: | OnQ Neuro |
| Classification | Automated Radiological Image Processing Software |
| Applicant | CorTechs Labs, Inc 5060 Shoreham Place, Suite 240 San Diego, CA 92122 |
| Contact | Kora Marinkovic |
| Correspondent | Kora Marinkovic CorTechs Labs, Inc 5060 Shoreham Place, Suite 240 San Diego, CA 92122 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-19 |
| Decision Date | 2021-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000004824 | K210831 | 000 |