Swoop® Portable MR Imaging® System (V2) is an AI-enabled medical device from Hyperfine, Inc., listed by FDA (510(k), K250236) with a decision date of 2025-05-30. Review panel: Radiology.
| FDA submission number | K250236 |
|---|---|
| Pathway | 510(k) |
| Company | Hyperfine, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-05-30 |
| Decision | Substantially Equivalent |
| Product code | LNH |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Device class | 2 |
| Regulation number | 892.1000 |
| Review time (calendar days) | 123 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.