Radiology
Swoop® Portable MR Imaging® System (V2)
Hyperfine, Inc.
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K250236
- Decision date
- May 2025
- FDA panel
- Radiology
- Product code
- LNH
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.