K241607
- 510(k) number
- K241607
- Device name
- MyoStrain (6.0)
- Applicant
- Myocardial Solutions, Inc. NC · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2024-08-26
- Date received
- 2024-06-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241607.pdf
Official FDA record: K241607
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.