K251276
- 510(k) number
- K251276
- Device name
- Swoop® Portable MR Imaging® System
- Applicant
- Hyperfine, Inc. CT · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2025-05-21
- Date received
- 2025-04-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251276.pdf
Official FDA record: K251276
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.