K242258
- 510(k) number
- K242258
- Device name
- MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)
- Applicant
- Asg Superconductors S.P.A. IT
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2024-11-26
- Date received
- 2024-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 4.2 MB · U.S. public domain
Also available from FDA: K242258.pdf
Official FDA record: K242258
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.