Class Class II
Swoop® Portable MR Imaging System™ (K230208)
Description
Swoop® Portable MR Imaging System™ by Hyperfine, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230208
Clearance Date2023-02-22
Clearance TypeSpecial
Product CodeLNH
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230208
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™ (K230208) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223247 | Swoop Portable MR Imaging System | Hyperfine, Inc. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232760 | Swoop® Portable MR Imaging System® | Hyperfine, Inc. | 2023 |
Trace the full predicate network for K230208
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.