K250236
- 510(k) number
- K250236
- Device name
- Swoop® Portable MR Imaging® System (V2)
- Applicant
- Hyperfine, Inc. CT · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2025-05-30
- Date received
- 2025-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250236.pdf
Official FDA record: K250236
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.