The following data is part of a premarket notification filed by Hyperfine Research, Inc with the FDA for Braininsight.
| Device ID | K202414 |
| 510k Number | K202414 |
| Device Name: | BrainInsight |
| Classification | System, Image Processing, Radiological |
| Applicant | Hyperfine Research, Inc 530 Old Whitfield St. Guilford, CT 06437 |
| Contact | Robert Fasciano |
| Correspondent | Robert Fasciano Hyperfine Research, Inc 530 Old Whitfield St. Guilford, CT 06437 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-24 |
| Decision Date | 2021-01-07 |