The following data is part of a premarket notification filed by Medimagemetric Llc with the FDA for Qsm Software, Qsmetric.
| Device ID | K210415 |
| 510k Number | K210415 |
| Device Name: | QSM Software, QSMetric |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Medimagemetric LLC 171 Floral Ave Johnson City, NY 13790 |
| Contact | Yi Wang |
| Correspondent | Yi Wang Medimagemetric LLC 455 Main Street, #7H New York, NY 10044 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-11 |
| Decision Date | 2021-07-22 |