The following data is part of a premarket notification filed by Myocardial Solutions with the FDA for Myostrain 5.1.
| Device ID | K182756 |
| 510k Number | K182756 |
| Device Name: | MyoStrain 5.1 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Myocardial Solutions 3000 RDU Center Drive, Suite 117 Morrisville, NC 27560 |
| Contact | Linda Horne |
| Correspondent | Linda Horne Myocardial Solutions 3000 RDU Center Drive, Suite 117 Morrisville, NC 27560 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B672MYOSTRAIN050102 | K182756 | 000 |
| B673MYOSTRAIN0502030 | K182756 | 000 |