Class Class II
Swoop® Portable MR Imaging® System (K253489)
Description
Swoop® Portable MR Imaging® System by Hyperfine, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK253489
Clearance Date2025-12-12
Clearance TypeSpecial
Product CodeLNH
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K253489
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Swoop® Portable MR Imaging® System (K253489) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K262622 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2026 |
Trace the full predicate network for K253489
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.