510(k) K182756
K182756 is an FDA 510(k) premarket notification submitted by Myocardial Solutions for the device "MyoStrain 5.1". The FDA issued a decision of Substantially Equivalent on February 14, 2019. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Myocardial Solutions has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2019
- Date Received
- September 28, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type