The following data is part of a premarket notification filed by Hyperfine Research, Inc. with the FDA for Hyperfine Point-of-care Magnetic Resonance Imaging (poc Mri) Scanner System.
| Device ID | K201722 |
| 510k Number | K201722 |
| Device Name: | Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Hyperfine Research, Inc. 530 Old Whitfield Street Guilford, CT 06437 |
| Contact | Robert Fasciano |
| Correspondent | Robert Fasciano Hyperfine Research, Inc. 530 Old Whitfield Street Guilford, CT 06437 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-23 |
| Decision Date | 2020-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000606158 | K201722 | 000 |
| 00860000606141 | K201722 | 000 |
| 00860000606134 | K201722 | 000 |
| 00860000606172 | K201722 | 000 |
| 00860000606165 | K201722 | 000 |