K253489
- 510(k) number
- K253489
- Device name
- Swoop® Portable MR Imaging® System
- Applicant
- Hyperfine, Inc. CT · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2025-12-12
- Date received
- 2025-10-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253489.pdf
Official FDA record: K253489
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.