K242006
- 510(k) number
- K242006
- Device name
- SureWave Elastography (Q7000225)
- Applicant
- Quality Electrodynamics, LLC OH · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2025-02-12
- Date received
- 2024-07-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K242006.pdf
Official FDA record: K242006
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.